<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03022799</url>
  </required_header>
  <id_info>
    <org_study_id>KMCP-819-K101</org_study_id>
    <nct_id>NCT03022799</nct_id>
  </id_info>
  <brief_title>Phase I, KM-819 in Healthy Subjects for Parkinson's Disease</brief_title>
  <official_title>A First in Human, Randomized, Double-blind, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Single and Multiple Oral Doses of KM-819 in Healthy Young Adult and Elderly Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kainos Medicine Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kainos Medicine Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This first in human, single-center, randomized, placebo-controlled, double blind, sequential&#xD;
      group Phase 1 study in healthy subjects will be conducted to evaluate the safety,&#xD;
      tolerability, PK, and PD following the escalation of single and multiple doses of KM-819.&#xD;
&#xD;
      The study will consist of 2 parts. In Part A, up to 5 cohorts of young adult male subjects,&#xD;
      and 1 single dose cohort of elderly male or post menopausal female subjects will receive&#xD;
      escalating single doses of KM-819. In Part B, up to 4 cohorts of healthy young adult male&#xD;
      subjects and 1 multiple dose cohort of elderly male or post menopausal female subjects will&#xD;
      receive escalating multiple doses of KM-819. Part B will be conducted after completion of all&#xD;
      cohorts of young adult male subjects in Part A.&#xD;
&#xD;
      Dose escalation to the next level will be determined using safety, tolerability, and PK data&#xD;
      of the previous cohort.&#xD;
&#xD;
      Part A, Single Ascending Dose (SAD) Up to 40 healthy young adult male subjects and 8 healthy&#xD;
      elderly male or post menopausal female subjects will be enrolled and randomized to receive&#xD;
      either KM-819 or placebo.&#xD;
&#xD;
      Each of the 5 dose escalation cohorts consists of 8 healthy young adult male subjects; 6&#xD;
      subjects will receive 10, 30, 100, 200, or 400 mg of KM-819 and 2 subjects will receive&#xD;
      placebo. In each single dose cohort, dosing of subjects will be sentinel, i.e., 2 subjects&#xD;
      will be dosed on the first day (1 subject will receive active treatment and 1 subject will&#xD;
      receive placebo) and the remaining 6 subjects will be dosed at least 24 hours after the first&#xD;
      2 subjects.&#xD;
&#xD;
      Cohorts will be dosed sequentially with escalating doses. Eight elderly male or&#xD;
      post-menopausal female subjects will be enrolled into an additional cohort; 6 subjects will&#xD;
      receive 200 mg KM-819 and 2 subjects will receive placebo.&#xD;
&#xD;
      Part A consists of a Screening period of up to 28 days, and a 3 day Confinement period when&#xD;
      subjects are hospitalized for study activities. Subjects are required to return for&#xD;
      outpatient visits on Day 4, 7 and for the Follow up Visit on Day 14.&#xD;
&#xD;
      Part B, Multiple Ascending Dose (MAD) Up to 32 healthy young adult male subjects and 8&#xD;
      healthy elderly male or post menopausal female subjects will be enrolled and randomized to&#xD;
      receive either KM-819 or placebo.&#xD;
&#xD;
      Each of the 4 dose escalation cohorts consists of 8 healthy young adult male subjects; 6&#xD;
      subjects will receive 30, 100, 200, or 400 mg of KM-819 once a day (QD) for 7 days and 2&#xD;
      subjects will receive placebo. Cohorts will be dosed sequentially with escalating doses.&#xD;
&#xD;
      Eight elderly male or post-menopausal female subjects will be enrolled into an additional&#xD;
      cohort; 6 subjects will receive 200 mg KM-819 QD for 7 days and 2 subjects will receive&#xD;
      placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.</time_frame>
    <description>All AEs will be coded using the latest available version 19.1 of the Medical Dictionary for Regulatory Activities (MedDRA).&#xD;
A treatment-emergent adverse event (TEAE) is defined as an AE that begins or that worsens in severity after at least one dose of the study drug has been administered.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (Maximum Plasma Concentration Determined Directly From the Concentration-time Profile)</measure>
    <time_frame>Part A: Day1 to Day 4. Part B: Day-1 to Day 8</time_frame>
    <description>To evaluate Cmax of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax (Time to Achieve Maximum Observed Plasma Concentration Determined Directly From the Concentration-time Profile)</measure>
    <time_frame>Part A:Day 1 to 4; Part B: Day 1 to Day 8</time_frame>
    <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ (Apparent Terminal Elimination Half Life)</measure>
    <time_frame>Part A: Day 1 to Day 4. Part B: Day1 to Day 8</time_frame>
    <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects. To evaluate the PK and PD of single and multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tlag (Lag Time)</measure>
    <time_frame>Part A: Day1 to Day 4. Part B: Day 1 to Day 8</time_frame>
    <description>To evaluate the T lag of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast (Area Under the Plasma Concentration-time From Predose (Time 0) to the Last Quantifiable Concentration)</measure>
    <time_frame>Part A: Day 1 to 4; Part B: Day 1 to Day 8</time_frame>
    <description>To evaluate AUClast of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCinf (Area Under the Plasma Concentration-time Curve From Predose (Time 0) Extrapolated to Infinity)</measure>
    <time_frame>Part A: Day 1 to 4; Part B: Day 1 to Day 8</time_frame>
    <description>To evaluate AUCinf of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male-subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>%AUCex (Percentage of AUCinf That is Due to Extrapolation Beyond Tlast)</measure>
    <time_frame>Part A: Day 1 to 4; Part B: Day 1 to Day 8</time_frame>
    <description>To evaluate %AUCex of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (Apparent Oral Clearance)</measure>
    <time_frame>Part A: Day 1 to 4; Part B: Day 1 to Day 8</time_frame>
    <description>To evaluate the CL/F of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (Apparent Volume of Distribution)</measure>
    <time_frame>Part A: Day 1 to 4; Part B: Day 1 to Day 8</time_frame>
    <description>To evaluate Vz/F of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCtau (Area Under the Plasma Concentration-time Curve for a Dosing Interval) (Part B)</measure>
    <time_frame>Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,</time_frame>
    <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rac(AUC) (Observed Accumulation by AUC) (Part B)</measure>
    <time_frame>Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,</time_frame>
    <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rac (Cmax) (Observed Accumulation by Cmax) (Part B)</measure>
    <time_frame>Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,</time_frame>
    <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCtau_D (AUCtau Divided by Dose) (Part B)</measure>
    <time_frame>Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,</time_frame>
    <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)</measure>
    <time_frame>At Day 1 (3 hours post dose), Day2, Day 3, Day 4, and Day 8.</time_frame>
    <description>The Bond-Lader Visual Analogue Scales (VAS) will be analyzed using 3 factor scores: alertness, contentedness, and calmness. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered. Baseline is defined as the last available recording prior to dosing on Day 1.&#xD;
Alertness (Range 0 to 100, the higher scores indicated more alertness)&#xD;
Mood (Range 0 to 100, where higher scores indicated elevated mood)&#xD;
Calmness (Range 0 to 100, where higher scores indicated more calmness).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Korean Wechsler Adult Intelligence Scale-IV (K-WAIS-IV)</measure>
    <time_frame>Part A: Day 1; Part B: Day 7</time_frame>
    <description>The K-WAIS-IV consists of an assessment of the cognitive ability using a core battery of 10 unique subtests (Block Design, Similarities, Digit Span, Matrix Reasoning, Vocabulary, Arithmetic, Symbol Search, Visual Puzzles, Information, and Coding) that focus on four specific domains of intelligence: verbal comprehension, perceptual reasoning, working memory, and processing speed. The Verbal Comprehension Index, Perceptual Reasoning Index, Working Memory Index, and Processing Speed Index (standard scores: mean=100, standard deviation=15) that are all based on a number of core and supplemental subtests (scaled scores: mean=15, standard deviation=3) that provide pertinent clinical information and flexibility in implementation. The higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alpha Synuclein Oligomer in Plasma and CSF (Part B)</measure>
    <time_frame>Plasma - Part B: Day 7 (at 1 hour after last dosing) / CSF - Part B: Day 7 (at 1 hour after last dosing)</time_frame>
    <description>To evaluate Alpha synuclein oligomer in plasma and CSF of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Total Tau in CSF (Part B)</measure>
    <time_frame>CSF - Part B: Day 1 (at -120 minutes to 0 minute prior to the first dosing) and on Day 7 (at 1 hour after last dosing)</time_frame>
    <description>To evaluate Total Tau in CSF of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Phospho-Tau in CSF (Part B)</measure>
    <time_frame>CSF - Part B: Day 1 (at -120 minutes to 0 minute prior to the first dosing) and on Day 7 (at 1 hour after last dosing)</time_frame>
    <description>To evaluate Phospho-Tau of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of CSF Concentration/Plasma Cmax (Part B)</measure>
    <time_frame>Plasma - Part B: Day 7 (at 1 hour after last dosing) / CSF - Part B: on Day 7 (at 1 hour after last dosing)</time_frame>
    <description>Ratio of CSF concentration/Plasma Cmax</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>KM-819</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each cohort consists of 8 subjects; 6 subjects will receive planned dose of KM-819 and 2 subjects will receive placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Each cohort consists of 8 subjects; 6 subjects will receive planned dose of KM-819 and 2 subjects will receive placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KM-819</intervention_name>
    <arm_group_label>KM-819</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written&#xD;
             informed consent and privacy language as per national regulations must be obtained&#xD;
             from the subject prior to any study-related procedures (including withdrawal of&#xD;
             prohibited medication, if applicable).&#xD;
&#xD;
          2. Male subject should be 19 to 45 years old (for young adult cohorts) or over 60 years&#xD;
             old (for elderly cohorts).&#xD;
&#xD;
          3. Subject has a body mass index (BMI) range of 18.5 to 30 kg/m2 inclusive at Screening.&#xD;
&#xD;
          4. Male subject and his female spouse/partner who is of childbearing potential must be&#xD;
             using highly effective contraception consisting of 2 forms of birth control (at least&#xD;
             one of which must be a barrier method) starting at Screening and continuing throughout&#xD;
             the study period and for 90 days after final study drug administration. Highly&#xD;
             effective contraception is defined as:&#xD;
&#xD;
               -  Established use of oral, injected, or implanted hormonal methods of contraception&#xD;
&#xD;
               -  Placement of an intrauterine device or intrauterine system&#xD;
&#xD;
               -  Barrier methods of contraception: condom with spermicidal foam, gel, film, cream,&#xD;
                  suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal&#xD;
                  foam, gel, film, cream, or suppository&#xD;
&#xD;
          5. Male subject must not donate sperm starting at Screening, throughout the study period&#xD;
             and for at least 90 days after final study drug administration.&#xD;
&#xD;
          6. Female subject must be over 60 years old and post-menopausal (defined as at least 1&#xD;
             year without any menses) prior to Screening.&#xD;
&#xD;
          7. Subject agrees not to participate in another investigational study while on study&#xD;
             treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a known or suspected hypersensitivity to KM-819, or any components of the&#xD;
             formulation(s) used.&#xD;
&#xD;
          2. Subject has previously participated in a clinical study with KM-819.&#xD;
&#xD;
          3. Subject has any of the liver enzymes (aspartate aminotransferase [AST], alanine&#xD;
             transaminase [ALT], alkaline phosphatase, γ glutamyl transferase) or total bilirubin&#xD;
             (TBIL) above the ULN. If any liver enzyme is &gt; 1 × ULN but &lt; 1.5 × ULN, the assessment&#xD;
             may be repeated once during the Screening period or on check-in. If the repeated&#xD;
             assessment is above the ULN, it is exclusionary. If the initial value is &gt; 1.5 × ULN,&#xD;
             it cannot be repeated and is exclusionary.&#xD;
&#xD;
          4. Subject has any clinically significant history of allergic conditions (including drug&#xD;
             allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated,&#xD;
             allergic rhinitis or rhino-conjunctivitis, or house dust mite allergy at time of&#xD;
             dosing).&#xD;
&#xD;
          5. Subject with a history of a suicide attempt or suicidal behavior. Any recent suicidal&#xD;
             ideation (a level of 4 or 5) within the last 3 months, or having a positive C-SSRS at&#xD;
             check-in (Day -1), or who is at significant risk to commit suicide, as judged by the&#xD;
             Investigator using the C SSRS at Screening.&#xD;
&#xD;
          6. Subject has/had febrile illness or symptomatic viral, bacterial (including upper&#xD;
             respiratory infection) or fungal (non-cutaneous) infection within 1 week before site&#xD;
             check-in.&#xD;
&#xD;
          7. Subject has any clinically significant abnormality following the Investigator's review&#xD;
             of the physical examination, ECG, and protocol-defined clinical laboratory tests at&#xD;
             Screening or site check-in.&#xD;
&#xD;
          8. Subject has a mean pulse &lt; 40 or &gt; 90 beats per minute (bpm); mean systolic blood&#xD;
             pressure (SBP) &gt; 140 mmHg; or mean diastolic blood pressure (DBP) &gt; 90 mmHg&#xD;
             (measurements taken in triplicate after subject has been resting in the supine&#xD;
             position for 5 minutes; pulse will be measured automatically) at Screening or&#xD;
             check-in. If the mean pulse, mean SBP, or mean DBP is out of the range specified&#xD;
             above, 1 additional triplicate measurement may be taken at Screening and check-in.&#xD;
&#xD;
          9. Subject has a mean QTcF interval of &gt; 430 msec (for males) and &gt; 450 msec (for&#xD;
             females) at Screening or check-in. If the mean QTcF exceeds the limits above, 1&#xD;
             additional triplicate ECG can be taken. If this triplicate also gives an abnormal&#xD;
             result, the subject should be excluded.&#xD;
&#xD;
         10. Subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac&#xD;
             arrhythmias or torsade de pointes, structural heart disease, or a family history of&#xD;
             Long QT Syndrome.&#xD;
&#xD;
         11. Subject has use of any prescribed or non-prescribed drugs (including vitamins, hormone&#xD;
             replacement therapy, natural and herbal remedies, e.g., St. John's Wort) in the 2&#xD;
             weeks before study drug administration. Acetaminophen up to 2000 mg/day is allowed.&#xD;
&#xD;
         12. Subject has had any use of tobacco- or nicotine-containing products within 6 months&#xD;
             prior to Screening.&#xD;
&#xD;
         13. Subject has history of consuming more than 14 units of alcoholic beverages per week&#xD;
             within 6 months prior to Screening or has a history of alcoholism or abuse of&#xD;
             amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates&#xD;
             (drugs-of-abuse) within the past 2 years prior to Screening (Note: 1 unit = 355 mL of&#xD;
             beer, 118 mL of wine, or 29 mL of spirits/hard liquor) or the subject tests positive&#xD;
             at Screening or site admission for alcohol or drugs of-abuse.&#xD;
&#xD;
         14. Subject has used any drugs-of-abuse within 3 months before check in.&#xD;
&#xD;
         15. Subject has used any inducers of metabolism (e.g., barbiturates, rifampin) in the 3&#xD;
             months prior to check-in.&#xD;
&#xD;
         16. Subject has any significant blood loss, donated 1 unit (450 mL) of blood or more, or&#xD;
             received a transfusion of any blood, or blood products within 60 days or donated&#xD;
             plasma within 7 days before check-in.&#xD;
&#xD;
         17. Subject has a positive serology test for hepatitis B surface antigen (HbsAg), anti&#xD;
             hepatitis A virus Immunoglobulin M (HAV IgM), anti-hepatitis C virus (HCV Ab), or&#xD;
             anti-human immunodeficiency virus (HIV Ab).&#xD;
&#xD;
         18. Subject has participated in any interventional clinical study or has been treated with&#xD;
             any investigational drugs within 3 months or 5 half lives, whichever is longer, before&#xD;
             the initiation of Screening.&#xD;
&#xD;
         19. Subject has (recent history of) any other condition which, in the opinion of the&#xD;
             Investigator, precludes the subject's participation in the trial.&#xD;
&#xD;
         20. Subject is an employee of the Kainos Medicine, Inc. or vendors involved in the study.&#xD;
&#xD;
             Additional Exclusion Criteria for Young Adult Subjects&#xD;
&#xD;
         21. For young adult cohorts, subject has any history or evidence of any clinically&#xD;
             significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic,&#xD;
             immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric,&#xD;
             renal, and/or other major disease or malignancy, as judged by the Investigator or&#xD;
             designee.&#xD;
&#xD;
        Exclusion Criteria for Elderly Subjects Replacement for Exclusion No. 8 above 8. Subject&#xD;
        has a mean pulse &lt; 50 or &gt; 90 bpm; mean SBP &gt; 160 mmHg; mean DBP &gt; 100 mmHg (measurements&#xD;
        taken in triplicate after subject has been resting in supine position for 5 minutes; pulse&#xD;
        will be measured automatically).&#xD;
&#xD;
        Replacement for Exclusion No. 21 above 21. For elderly cohorts, subject has any history or&#xD;
        evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic,&#xD;
        hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic,&#xD;
        dermatologic, psychiatric, renal, and/or other major disease or malignancy that is not well&#xD;
        managed and stable, as judged by the Investigator or designee.&#xD;
&#xD;
        Additional Exclusion Criteria 22. Elderly subject is excluded if the Glomerular Filtration&#xD;
        Rate (calculated based on Cockcroft-Gault formula) is &lt; 60 mL/min/1.73 m2.&#xD;
&#xD;
        23. Clinically significant abnormal findings in the lumbar X-ray examination (only for&#xD;
        elder subjects for MAD study).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jae Moon Lee, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Kainos Medicine Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHA Bundang Medical Center, CHA University</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi-do</state>
        <zip>13496</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <results_first_submitted>November 28, 2018</results_first_submitted>
  <results_first_submitted_qc>March 31, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 13, 2020</results_first_posted>
  <last_update_submitted>March 31, 2020</last_update_submitted>
  <last_update_submitted_qc>March 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FAF1</keyword>
  <keyword>Fas (TNFRSF6)-associated factor 1</keyword>
  <keyword>FAF1 inhibitor</keyword>
  <keyword>KM-819</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Individual identifiable personal information will not be shared. All individuals will be coded by a 4-digit study code.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03022799/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03022799/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03022799/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A first in human, single center, randomized, placebo controlled, double blind, sequential group Phase 1 study in healthy subjects recruited from Nov 2016 to Sep 2017. Participants who met all the inclusion and none of the exclusion criteria were enrolled.</recruitment_details>
      <pre_assignment_details>All subjects underwent a Screening period of up to 28 days and a 3 day Confinement period when they were hospitalized for study activities (Day -1 to Day 3) for Part A (Single Ascending Doses) and an 8 day Confinement period when they were hospitalized for study activities (Day -1 to Day 8) for Part B (Multiple Ascending Doses)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>KM-819 - 10 mg (Part A)</title>
          <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="P2">
          <title>KM-819 - 30 mg (Part A)</title>
          <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="P3">
          <title>KM-819 - 100mg (Part A)</title>
          <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="P4">
          <title>KM-819 200mg (Part A)</title>
          <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="P5">
          <title>KM-819 - 400mg (Part A)</title>
          <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="P6">
          <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
          <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="P7">
          <title>Placebo (Part A)</title>
          <description>12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="P8">
          <title>KM-819 30 mg (Part B)</title>
          <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="P9">
          <title>KM-819 100 mg (Part B)</title>
          <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="P10">
          <title>KM-819 200mg (Part B)</title>
          <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="P11">
          <title>KM-819 400mg (Part B)</title>
          <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="P12">
          <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
          <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="P13">
          <title>Placebo (Part B)</title>
          <description>10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="12"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="6"/>
                <participants group_id="P12" count="6"/>
                <participants group_id="P13" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="12"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="5"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="6"/>
                <participants group_id="P13" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>KM-819 - 10 mg (Part A)</title>
          <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="B2">
          <title>KM-819 - 30 mg (Part A)</title>
          <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="B3">
          <title>KM-819 - 100mg (Part A)</title>
          <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="B4">
          <title>KM-819 200mg (Part A)</title>
          <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="B5">
          <title>KM-819 - 400mg (Part A)</title>
          <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="B6">
          <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
          <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="B7">
          <title>Placebo (Part A)</title>
          <description>12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="B8">
          <title>KM-819 30 mg (Part B)</title>
          <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="B9">
          <title>KM-819 100 mg (Part B)</title>
          <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="B10">
          <title>KM-819 200mg (Part B)</title>
          <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="B11">
          <title>KM-819 400mg (Part B)</title>
          <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="B12">
          <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
          <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="B13">
          <title>Placebo (Part B)</title>
          <description>10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="B14">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="12"/>
            <count group_id="B8" value="6"/>
            <count group_id="B9" value="6"/>
            <count group_id="B10" value="6"/>
            <count group_id="B11" value="6"/>
            <count group_id="B12" value="6"/>
            <count group_id="B13" value="10"/>
            <count group_id="B14" value="88"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.7" spread="6.28"/>
                    <measurement group_id="B2" value="25.2" spread="7.57"/>
                    <measurement group_id="B3" value="26.2" spread="5.04"/>
                    <measurement group_id="B4" value="27.5" spread="6.38"/>
                    <measurement group_id="B5" value="26.3" spread="4.13"/>
                    <measurement group_id="B6" value="75.0" spread="5.76"/>
                    <measurement group_id="B7" value="35.6" spread="19.76"/>
                    <measurement group_id="B8" value="27.5" spread="7.56"/>
                    <measurement group_id="B9" value="30.2" spread="6.85"/>
                    <measurement group_id="B10" value="28.7" spread="5.65"/>
                    <measurement group_id="B11" value="22.5" spread="1.38"/>
                    <measurement group_id="B12" value="72.8" spread="6.59"/>
                    <measurement group_id="B13" value="38.5" spread="19.73"/>
                    <measurement group_id="B14" value="35.3" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="6"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="10"/>
                    <measurement group_id="B14" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="6"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="10"/>
                    <measurement group_id="B14" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>All AEs will be coded using the latest available version 19.1 of the Medical Dictionary for Regulatory Activities (MedDRA).&#xD;
A treatment-emergent adverse event (TEAE) is defined as an AE that begins or that worsens in severity after at least one dose of the study drug has been administered.</description>
        <time_frame>From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.</time_frame>
        <population>All subjects who received at least one dose.</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 - 10 mg (Part A)</title>
            <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 - 30 mg (Part A)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 - 100mg (Part A)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 200mg (Part A)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 - 400mg (Part A)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
            <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part A)</title>
            <description>12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O8">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O9">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O10">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours</description>
          </group>
          <group group_id="O11">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O12">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O13">
            <title>Placebo (Part B)</title>
            <description>10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>All AEs will be coded using the latest available version 19.1 of the Medical Dictionary for Regulatory Activities (MedDRA).&#xD;
A treatment-emergent adverse event (TEAE) is defined as an AE that begins or that worsens in severity after at least one dose of the study drug has been administered.</description>
          <population>All subjects who received at least one dose.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="4"/>
                    <measurement group_id="O10" value="5"/>
                    <measurement group_id="O11" value="5"/>
                    <measurement group_id="O12" value="3"/>
                    <measurement group_id="O13" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="5"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="3"/>
                    <measurement group_id="O13" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs leading to withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs leading to death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax (Maximum Plasma Concentration Determined Directly From the Concentration-time Profile)</title>
        <description>To evaluate Cmax of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>Part A: Day1 to Day 4. Part B: Day-1 to Day 8</time_frame>
        <population>All subjects who received at least one dose.</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 - 10 mg (Part A)</title>
            <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 - 30 mg (Part A)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 - 100mg (Part A)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 200mg (Part A)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 - 400mg (Part A)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
            <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O7">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O8">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O9">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O10">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O11">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax (Maximum Plasma Concentration Determined Directly From the Concentration-time Profile)</title>
          <description>To evaluate Cmax of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="244.1" spread="31.4"/>
                    <measurement group_id="O2" value="503.6" spread="28.0"/>
                    <measurement group_id="O3" value="1152" spread="36.7"/>
                    <measurement group_id="O4" value="1879" spread="55.3"/>
                    <measurement group_id="O5" value="2767" spread="43.4"/>
                    <measurement group_id="O6" value="1766" spread="26.0"/>
                    <measurement group_id="O7" value="512.0" spread="30.9"/>
                    <measurement group_id="O8" value="1009" spread="33.0"/>
                    <measurement group_id="O9" value="1465" spread="77.2"/>
                    <measurement group_id="O10" value="3163" spread="50.7"/>
                    <measurement group_id="O11" value="3542" spread="76.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax (Time to Achieve Maximum Observed Plasma Concentration Determined Directly From the Concentration-time Profile)</title>
        <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>Part A:Day 1 to 4; Part B: Day 1 to Day 8</time_frame>
        <population>All subjects who received at least one dose.</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 - 10 mg (Part A)</title>
            <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 - 30 mg (Part A)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 - 100mg (Part A)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 200mg (Part A)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 - 400mg (Part A)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
            <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O7">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O8">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O9">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O10">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O11">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax (Time to Achieve Maximum Observed Plasma Concentration Determined Directly From the Concentration-time Profile)</title>
          <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.500" lower_limit="0.50" upper_limit="2.00"/>
                    <measurement group_id="O2" value="1.000" lower_limit="0.50" upper_limit="2.00"/>
                    <measurement group_id="O3" value="2.000" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O4" value="2.008" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O5" value="4.000" lower_limit="2.00" upper_limit="4.00"/>
                    <measurement group_id="O6" value="2.000" lower_limit="1.00" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B-Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="2.000" lower_limit="1.00" upper_limit="6.00"/>
                    <measurement group_id="O8" value="2.000" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O9" value="3.000" lower_limit="2.00" upper_limit="6.00"/>
                    <measurement group_id="O10" value="2.008" lower_limit="1.00" upper_limit="6.00"/>
                    <measurement group_id="O11" value="2.000" lower_limit="1.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B-Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="2.000" lower_limit="0.97" upper_limit="6.00"/>
                    <measurement group_id="O8" value="3.000" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O9" value="4.000" lower_limit="3.92" upper_limit="4.03"/>
                    <measurement group_id="O10" value="2.000" lower_limit="0.50" upper_limit="4.00"/>
                    <measurement group_id="O11" value="2.017" lower_limit="1.00" upper_limit="4.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>t½ (Apparent Terminal Elimination Half Life)</title>
        <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects. To evaluate the PK and PD of single and multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>Part A: Day 1 to Day 4. Part B: Day1 to Day 8</time_frame>
        <population>All subjects who received at least one dose</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 - 10 mg (Part A)</title>
            <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 - 30 mg (Part A)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 - 100mg (Part A)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 200mg (Part A)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 - 400mg (Part A)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
            <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O7">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O8">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O9">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O10">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O11">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>t½ (Apparent Terminal Elimination Half Life)</title>
          <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects. To evaluate the PK and PD of single and multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose</population>
          <units>Hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.786" spread="28.3"/>
                    <measurement group_id="O2" value="4.791" spread="25.0"/>
                    <measurement group_id="O3" value="9.159" spread="41.2"/>
                    <measurement group_id="O4" value="9.010" spread="71.6"/>
                    <measurement group_id="O5" value="8.527" spread="63.2"/>
                    <measurement group_id="O6" value="10.55" spread="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="3.075" spread="46.9"/>
                    <measurement group_id="O8" value="5.417" spread="15.1"/>
                    <measurement group_id="O9" value="5.785" spread="24.1"/>
                    <measurement group_id="O11" value="4.389" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tlag (Lag Time)</title>
        <description>To evaluate the T lag of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>Part A: Day1 to Day 4. Part B: Day 1 to Day 8</time_frame>
        <population>All subjects who received at least one dose.</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 - 10 mg (Part A)</title>
            <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 - 30 mg (Part A)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 - 100mg (Part A)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 200mg (Part A)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 - 400mg (Part A)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
            <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O7">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O8">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O9">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O10">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O11">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Tlag (Lag Time)</title>
          <description>To evaluate the T lag of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose.</population>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08333" spread="0.1291"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0" spread="0"/>
                    <measurement group_id="O4" value="0.04167" spread="0.1021"/>
                    <measurement group_id="O5" value="0" spread="0"/>
                    <measurement group_id="O6" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B-Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="0.04167" spread="0.1021"/>
                    <measurement group_id="O8" value="0.08333" spread="0.1291"/>
                    <measurement group_id="O9" value="0" spread="0"/>
                    <measurement group_id="O10" value="0" spread="0"/>
                    <measurement group_id="O11" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B-Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="5"/>
                    <count group_id="O10" value="5"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="0" spread="0"/>
                    <measurement group_id="O8" value="0" spread="0"/>
                    <measurement group_id="O9" value="0" spread="0"/>
                    <measurement group_id="O10" value="0" spread="0"/>
                    <measurement group_id="O11" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUClast (Area Under the Plasma Concentration-time From Predose (Time 0) to the Last Quantifiable Concentration)</title>
        <description>To evaluate AUClast of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>Part A: Day 1 to 4; Part B: Day 1 to Day 8</time_frame>
        <population>All subjects who received at least one dose.</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 - 10 mg (Part A)</title>
            <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 - 30 mg (Part A)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 - 100mg (Part A)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 200mg (Part A)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 - 400mg (Part A)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
            <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O7">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O8">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O9">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O10">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O11">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>AUClast (Area Under the Plasma Concentration-time From Predose (Time 0) to the Last Quantifiable Concentration)</title>
          <description>To evaluate AUClast of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose.</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="597.5" spread="140.5"/>
                    <measurement group_id="O2" value="1726" spread="289.7"/>
                    <measurement group_id="O3" value="4479" spread="1423"/>
                    <measurement group_id="O4" value="8210" spread="2912"/>
                    <measurement group_id="O5" value="12770" spread="4321"/>
                    <measurement group_id="O6" value="10880" spread="1108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B-Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="1786" spread="379.4"/>
                    <measurement group_id="O8" value="3944" spread="1453"/>
                    <measurement group_id="O9" value="7340" spread="3890"/>
                    <measurement group_id="O10" value="11880" spread="4525"/>
                    <measurement group_id="O11" value="19660" spread="11160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B-Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="1608" spread="414.2"/>
                    <measurement group_id="O8" value="3688" spread="686.0"/>
                    <measurement group_id="O9" value="6333" spread="2402"/>
                    <measurement group_id="O10" value="17330" spread="10900"/>
                    <measurement group_id="O11" value="17020" spread="5676"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUCinf (Area Under the Plasma Concentration-time Curve From Predose (Time 0) Extrapolated to Infinity)</title>
        <description>To evaluate AUCinf of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male-subjects.</description>
        <time_frame>Part A: Day 1 to 4; Part B: Day 1 to Day 8</time_frame>
        <population>All subjects who received at least one dose.</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 - 10 mg (Part A)</title>
            <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 - 30 mg (Part A)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 - 100mg (Part A)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 200mg (Part A)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 - 400mg (Part A)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
            <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O7">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O8">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O9">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O10">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O11">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>AUCinf (Area Under the Plasma Concentration-time Curve From Predose (Time 0) Extrapolated to Infinity)</title>
          <description>To evaluate AUCinf of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male-subjects.</description>
          <population>All subjects who received at least one dose.</population>
          <units>h*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="594.2" spread="24.4"/>
                    <measurement group_id="O2" value="1731" spread="17.3"/>
                    <measurement group_id="O3" value="4872" spread="30.8"/>
                    <measurement group_id="O4" value="7338" spread="51.9"/>
                    <measurement group_id="O5" value="12640" spread="36.1"/>
                    <measurement group_id="O6" value="10970" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B-Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="1713" spread="22.4"/>
                    <measurement group_id="O8" value="3884" spread="41.5"/>
                    <measurement group_id="O9" value="10070" spread="30.8"/>
                    <measurement group_id="O11" value="18550" spread="57.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>%AUCex (Percentage of AUCinf That is Due to Extrapolation Beyond Tlast)</title>
        <description>To evaluate %AUCex of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>Part A: Day 1 to 4; Part B: Day 1 to Day 8</time_frame>
        <population>All subjects who received at least one dose.</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 - 10 mg (Part A)</title>
            <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 - 30 mg (Part A)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 - 100mg (Part A)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 200mg (Part A)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 - 400mg (Part A)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
            <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O7">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O8">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O9">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O10">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O11">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>%AUCex (Percentage of AUCinf That is Due to Extrapolation Beyond Tlast)</title>
          <description>To evaluate %AUCex of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose.</population>
          <units>percentage of AUC</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.664" spread="50.5"/>
                    <measurement group_id="O2" value="1.331" spread="51.2"/>
                    <measurement group_id="O3" value="1.338" spread="19.0"/>
                    <measurement group_id="O4" value="0.7787" spread="65.4"/>
                    <measurement group_id="O5" value="0.4833" spread="164.4"/>
                    <measurement group_id="O6" value="0.9795" spread="77.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="3"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="1.273" spread="43.9"/>
                    <measurement group_id="O8" value="3.075" spread="63.3"/>
                    <measurement group_id="O9" value="2.263" spread="84.8"/>
                    <measurement group_id="O11" value="1.982" spread="112.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CL/F (Apparent Oral Clearance)</title>
        <description>To evaluate the CL/F of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>Part A: Day 1 to 4; Part B: Day 1 to Day 8</time_frame>
        <population>All subjects who received at least one dose.</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 - 10 mg (Part A)</title>
            <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 - 30 mg (Part A)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 - 100mg (Part A)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 200mg (Part A)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 - 400mg (Part A)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
            <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O7">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O8">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O9">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O10">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O11">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>CL/F (Apparent Oral Clearance)</title>
          <description>To evaluate the CL/F of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose.</population>
          <units>mL/h</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16830" spread="24.4"/>
                    <measurement group_id="O2" value="17340" spread="17.3"/>
                    <measurement group_id="O3" value="20530" spread="30.8"/>
                    <measurement group_id="O4" value="27260" spread="51.9"/>
                    <measurement group_id="O5" value="31650" spread="36.1"/>
                    <measurement group_id="O6" value="18230" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B-Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="17520" spread="22.4"/>
                    <measurement group_id="O8" value="25740" spread="41.5"/>
                    <measurement group_id="O9" value="19860" spread="30.8"/>
                    <measurement group_id="O11" value="10780" spread="57.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B-Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="19090" spread="24.8"/>
                    <measurement group_id="O8" value="28760" spread="17.9"/>
                    <measurement group_id="O9" value="24930" spread="7.7"/>
                    <measurement group_id="O10" value="20480" spread="96.4"/>
                    <measurement group_id="O11" value="12300" spread="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vz/F (Apparent Volume of Distribution)</title>
        <description>To evaluate Vz/F of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>Part A: Day 1 to 4; Part B: Day 1 to Day 8</time_frame>
        <population>All subjects who received at least one dose.</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 - 10 mg (Part A)</title>
            <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 - 30 mg (Part A)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 - 100mg (Part A)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 200mg (Part A)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 - 400mg (Part A)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
            <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O7">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O8">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O9">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O10">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O11">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Vz/F (Apparent Volume of Distribution)</title>
          <description>To evaluate Vz/F of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose.</population>
          <units>mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43370" spread="18.8"/>
                    <measurement group_id="O2" value="119800" spread="23.5"/>
                    <measurement group_id="O3" value="271200" spread="56.6"/>
                    <measurement group_id="O4" value="354300" spread="114.0"/>
                    <measurement group_id="O5" value="389300" spread="49.5"/>
                    <measurement group_id="O6" value="277500" spread="27.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B-Day1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="77710" spread="32.9"/>
                    <measurement group_id="O8" value="201200" spread="57.6"/>
                    <measurement group_id="O9" value="165700" spread="58.1"/>
                    <measurement group_id="O11" value="68250" spread="72.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part B-Day7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="143400" spread="33.5"/>
                    <measurement group_id="O8" value="241300" spread="23.6"/>
                    <measurement group_id="O9" value="171400" spread="7.4"/>
                    <measurement group_id="O10" value="187100" spread="151.8"/>
                    <measurement group_id="O11" value="88200" spread="64.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUCtau (Area Under the Plasma Concentration-time Curve for a Dosing Interval) (Part B)</title>
        <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,</time_frame>
        <population>All subjects who received at least one dose in Part B</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>AUCtau (Area Under the Plasma Concentration-time Curve for a Dosing Interval) (Part B)</title>
          <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose in Part B</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1612" lower_limit="1130" upper_limit="2320"/>
                    <measurement group_id="O2" value="3521" lower_limit="2760" upper_limit="4290"/>
                    <measurement group_id="O3" value="8039" lower_limit="7670" upper_limit="8770"/>
                    <measurement group_id="O4" value="22830" lower_limit="11000" upper_limit="34700"/>
                    <measurement group_id="O5" value="17020" lower_limit="11000" upper_limit="25800"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rac(AUC) (Observed Accumulation by AUC) (Part B)</title>
        <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,</time_frame>
        <population>All subjects who received at least one dose in Part B</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Rac(AUC) (Observed Accumulation by AUC) (Part B)</title>
          <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose in Part B</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8926" lower_limit="0.70" upper_limit="1.13"/>
                    <measurement group_id="O2" value="0.9727" lower_limit="0.69" upper_limit="1.37"/>
                    <measurement group_id="O3" value="0.7568" lower_limit="0.57" upper_limit="1.00"/>
                    <measurement group_id="O4" value="1.485" lower_limit="0.86" upper_limit="2.56"/>
                    <measurement group_id="O5" value="0.9241" lower_limit="0.67" upper_limit="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rac (Cmax) (Observed Accumulation by Cmax) (Part B)</title>
        <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,</time_frame>
        <population>All subjects who received at least one dose in Part B</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Rac (Cmax) (Observed Accumulation by Cmax) (Part B)</title>
          <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose in Part B</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8173" lower_limit="0.53" upper_limit="1.26"/>
                    <measurement group_id="O2" value="1.003" lower_limit="0.73" upper_limit="1.39"/>
                    <measurement group_id="O3" value="0.6227" lower_limit="0.55" upper_limit="0.71"/>
                    <measurement group_id="O4" value="1.117" lower_limit="1.00" upper_limit="1.25"/>
                    <measurement group_id="O5" value="0.9122" lower_limit="0.53" upper_limit="1.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUCtau_D (AUCtau Divided by Dose) (Part B)</title>
        <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,</time_frame>
        <population>All subjects who received at least one dose in Part B</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>AUCtau_D (AUCtau Divided by Dose) (Part B)</title>
          <description>To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose in Part B</population>
          <units>(h*ng/mL)/mg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.74" lower_limit="37.7" upper_limit="77.4"/>
                    <measurement group_id="O2" value="35.21" lower_limit="27.6" upper_limit="42.9"/>
                    <measurement group_id="O3" value="40.19" lower_limit="38.3" upper_limit="43.6"/>
                    <measurement group_id="O4" value="57.08" lower_limit="27.5" upper_limit="86.6"/>
                    <measurement group_id="O5" value="85.09" lower_limit="55.1" upper_limit="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)</title>
        <description>The Bond-Lader Visual Analogue Scales (VAS) will be analyzed using 3 factor scores: alertness, contentedness, and calmness. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered. Baseline is defined as the last available recording prior to dosing on Day 1.&#xD;
Alertness (Range 0 to 100, the higher scores indicated more alertness)&#xD;
Mood (Range 0 to 100, where higher scores indicated elevated mood)&#xD;
Calmness (Range 0 to 100, where higher scores indicated more calmness).</description>
        <time_frame>At Day 1 (3 hours post dose), Day2, Day 3, Day 4, and Day 8.</time_frame>
        <population>All subjects who received at least one dose.</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 - 10 mg (Part A)</title>
            <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 - 30 mg (Part A)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 - 100mg (Part A)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 200mg (Part A)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 - 400mg (Part A)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
            <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part A)</title>
            <description>12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O8">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O9">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O10">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O11">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O12">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O13">
            <title>Placebo (Part B)</title>
            <description>10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)</title>
          <description>The Bond-Lader Visual Analogue Scales (VAS) will be analyzed using 3 factor scores: alertness, contentedness, and calmness. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered. Baseline is defined as the last available recording prior to dosing on Day 1.&#xD;
Alertness (Range 0 to 100, the higher scores indicated more alertness)&#xD;
Mood (Range 0 to 100, where higher scores indicated elevated mood)&#xD;
Calmness (Range 0 to 100, where higher scores indicated more calmness).</description>
          <population>All subjects who received at least one dose.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="5"/>
                <count group_id="O11" value="5"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alertness- Day 1, 3 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="5"/>
                    <count group_id="O11" value="4"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.482" spread="3.6349"/>
                    <measurement group_id="O2" value="-4.315" spread="8.8671"/>
                    <measurement group_id="O3" value="0.720" spread="7.2589"/>
                    <measurement group_id="O4" value="-3.610" spread="9.4171"/>
                    <measurement group_id="O5" value="-2.333" spread="6.4200"/>
                    <measurement group_id="O6" value="3.093" spread="3.7733"/>
                    <measurement group_id="O7" value="-2.926" spread="11.4835"/>
                    <measurement group_id="O8" value="7.058" spread="12.2168"/>
                    <measurement group_id="O9" value="3.445" spread="11.1990"/>
                    <measurement group_id="O10" value="9.264" spread="21.4350"/>
                    <measurement group_id="O11" value="-4.668" spread="4.6964"/>
                    <measurement group_id="O12" value="-0.128" spread="8.7694"/>
                    <measurement group_id="O13" value="2.088" spread="8.4283"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alertness-Day 2, 24 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="5"/>
                    <count group_id="O11" value="5"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.202" spread="5.4359"/>
                    <measurement group_id="O2" value="-0.465" spread="11.1985"/>
                    <measurement group_id="O3" value="-2.333" spread="3.4326"/>
                    <measurement group_id="O4" value="-0.148" spread="7.5707"/>
                    <measurement group_id="O5" value="-2.427" spread="5.7016"/>
                    <measurement group_id="O6" value="2.315" spread="4.8479"/>
                    <measurement group_id="O7" value="-0.171" spread="6.8216"/>
                    <measurement group_id="O8" value="0.093" spread="6.0070"/>
                    <measurement group_id="O9" value="-5.687" spread="9.4737"/>
                    <measurement group_id="O10" value="-0.222" spread="10.7325"/>
                    <measurement group_id="O11" value="-0.976" spread="6.2563"/>
                    <measurement group_id="O12" value="-3.760" spread="6.2182"/>
                    <measurement group_id="O13" value="0.566" spread="8.2926"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alertness-Day 3, 48 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.500" spread="6.2535"/>
                    <measurement group_id="O2" value="-2.278" spread="11.9110"/>
                    <measurement group_id="O3" value="-8.073" spread="8.6618"/>
                    <measurement group_id="O4" value="-3.128" spread="6.5867"/>
                    <measurement group_id="O5" value="-4.110" spread="8.6208"/>
                    <measurement group_id="O6" value="5.500" spread="5.2313"/>
                    <measurement group_id="O7" value="-4.572" spread="9.7416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alertness-Day 4, 72 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.665" spread="5.8359"/>
                    <measurement group_id="O2" value="-3.372" spread="8.8024"/>
                    <measurement group_id="O3" value="-6.352" spread="11.6716"/>
                    <measurement group_id="O4" value="-6.372" spread="6.0623"/>
                    <measurement group_id="O5" value="-3.368" spread="9.2123"/>
                    <measurement group_id="O6" value="3.222" spread="3.4213"/>
                    <measurement group_id="O7" value="-7.814" spread="7.5635"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calmness-Day 1, 3 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="5"/>
                    <count group_id="O11" value="5"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" spread="8.417"/>
                    <measurement group_id="O2" value="-3.08" spread="6.888"/>
                    <measurement group_id="O3" value="1.75" spread="9.832"/>
                    <measurement group_id="O4" value="-1.17" spread="9.852"/>
                    <measurement group_id="O5" value="0.25" spread="4.709"/>
                    <measurement group_id="O6" value="1.67" spread="5.279"/>
                    <measurement group_id="O7" value="-1.04" spread="6.580"/>
                    <measurement group_id="O8" value="-10.92" spread="18.400"/>
                    <measurement group_id="O9" value="1.33" spread="5.654"/>
                    <measurement group_id="O10" value="-1.00" spread="36.447"/>
                    <measurement group_id="O11" value="-12.30" spread="16.010"/>
                    <measurement group_id="O12" value="4.00" spread="17.593"/>
                    <measurement group_id="O13" value="1.40" spread="6.728"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calmness-Day 2, 24 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="5"/>
                    <count group_id="O11" value="5"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.42" spread="9.952"/>
                    <measurement group_id="O2" value="1.00" spread="9.290"/>
                    <measurement group_id="O3" value="-3.75" spread="13.080"/>
                    <measurement group_id="O4" value="3.42" spread="12.064"/>
                    <measurement group_id="O5" value="3.92" spread="3.513"/>
                    <measurement group_id="O6" value="0.83" spread="8.430"/>
                    <measurement group_id="O7" value="-0.63" spread="9.033"/>
                    <measurement group_id="O8" value="-7.33" spread="18.384"/>
                    <measurement group_id="O9" value="0.25" spread="3.504"/>
                    <measurement group_id="O10" value="-8.40" spread="13.093"/>
                    <measurement group_id="O11" value="-7.70" spread="20.092"/>
                    <measurement group_id="O12" value="8.25" spread="16.121"/>
                    <measurement group_id="O13" value="1.25" spread="6.233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calmness-Day 3, 48 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.42" spread="10.542"/>
                    <measurement group_id="O2" value="0.42" spread="7.651"/>
                    <measurement group_id="O3" value="-9.92" spread="9.388"/>
                    <measurement group_id="O4" value="-2.33" spread="4.502"/>
                    <measurement group_id="O5" value="3.58" spread="4.188"/>
                    <measurement group_id="O6" value="1.00" spread="5.138"/>
                    <measurement group_id="O7" value="-3.21" spread="10.310"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calmness-Day 4, 72 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.42" spread="11.160"/>
                    <measurement group_id="O2" value="3.33" spread="10.567"/>
                    <measurement group_id="O3" value="-8.50" spread="11.908"/>
                    <measurement group_id="O4" value="1.42" spread="7.807"/>
                    <measurement group_id="O5" value="6.58" spread="7.249"/>
                    <measurement group_id="O6" value="0.42" spread="4.443"/>
                    <measurement group_id="O7" value="-2.67" spread="8.446"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Contentedness-Day 1, 3 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="5"/>
                    <count group_id="O11" value="5"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.83" spread="6.770"/>
                    <measurement group_id="O2" value="-2.67" spread="3.355"/>
                    <measurement group_id="O3" value="-2.37" spread="3.194"/>
                    <measurement group_id="O4" value="-1.33" spread="1.473"/>
                    <measurement group_id="O5" value="-1.93" spread="6.822"/>
                    <measurement group_id="O6" value="-3.10" spread="13.121"/>
                    <measurement group_id="O7" value="0.90" spread="6.872"/>
                    <measurement group_id="O8" value="-1.80" spread="4.818"/>
                    <measurement group_id="O9" value="3.23" spread="5.251"/>
                    <measurement group_id="O10" value="2.52" spread="18.349"/>
                    <measurement group_id="O11" value="0.96" spread="3.542"/>
                    <measurement group_id="O12" value="-7.13" spread="6.565"/>
                    <measurement group_id="O13" value="-0.42" spread="3.294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Contentedness-Day 2, 24 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="5"/>
                    <count group_id="O11" value="5"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.13" spread="12.139"/>
                    <measurement group_id="O2" value="1.30" spread="5.383"/>
                    <measurement group_id="O3" value="-3.53" spread="3.384"/>
                    <measurement group_id="O4" value="1.03" spread="3.674"/>
                    <measurement group_id="O5" value="-0.73" spread="8.911"/>
                    <measurement group_id="O6" value="-0.53" spread="9.226"/>
                    <measurement group_id="O7" value="-1.43" spread="5.775"/>
                    <measurement group_id="O8" value="-3.63" spread="5.126"/>
                    <measurement group_id="O9" value="-2.23" spread="5.076"/>
                    <measurement group_id="O10" value="-5.12" spread="2.674"/>
                    <measurement group_id="O11" value="2.16" spread="9.459"/>
                    <measurement group_id="O12" value="-4.43" spread="5.321"/>
                    <measurement group_id="O13" value="-1.58" spread="2.978"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Contentedness-Day 3, 48 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.37" spread="13.125"/>
                    <measurement group_id="O2" value="-2.83" spread="5.159"/>
                    <measurement group_id="O3" value="-3.80" spread="5.374"/>
                    <measurement group_id="O4" value="-1.07" spread="3.840"/>
                    <measurement group_id="O5" value="-1.30" spread="6.549"/>
                    <measurement group_id="O6" value="0.37" spread="7.337"/>
                    <measurement group_id="O7" value="-2.30" spread="9.936"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Contentedness-Day 4, 72 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.00" spread="11.021"/>
                    <measurement group_id="O2" value="-0.80" spread="2.086"/>
                    <measurement group_id="O3" value="-3.13" spread="8.256"/>
                    <measurement group_id="O4" value="-3.23" spread="3.024"/>
                    <measurement group_id="O5" value="-3.93" spread="5.504"/>
                    <measurement group_id="O6" value="-1.60" spread="7.201"/>
                    <measurement group_id="O7" value="-4.83" spread="6.200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alertness-Day 8, 24 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="5"/>
                    <count group_id="O11" value="5"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O8" value="-2.282" spread="3.6448"/>
                    <measurement group_id="O9" value="-8.835" spread="8.3161"/>
                    <measurement group_id="O10" value="3.842" spread="9.4304"/>
                    <measurement group_id="O11" value="-7.358" spread="4.7420"/>
                    <measurement group_id="O12" value="-6.683" spread="15.6554"/>
                    <measurement group_id="O13" value="-2.834" spread="6.5374"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calmness-Day 8, 24 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="5"/>
                    <count group_id="O11" value="5"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O8" value="-7.75" spread="19.263"/>
                    <measurement group_id="O9" value="6.75" spread="14.754"/>
                    <measurement group_id="O10" value="1.90" spread="7.171"/>
                    <measurement group_id="O11" value="-6.10" spread="18.301"/>
                    <measurement group_id="O12" value="10.25" spread="16.825"/>
                    <measurement group_id="O13" value="1.40" spread="10.538"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Contentedness-Day 8, 24 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="5"/>
                    <count group_id="O11" value="5"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O8" value="-2.87" spread="5.731"/>
                    <measurement group_id="O9" value="-3.27" spread="2.738"/>
                    <measurement group_id="O10" value="-0.40" spread="2.429"/>
                    <measurement group_id="O11" value="-1.44" spread="7.249"/>
                    <measurement group_id="O12" value="-8.27" spread="8.068"/>
                    <measurement group_id="O13" value="-1.76" spread="6.983"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Korean Wechsler Adult Intelligence Scale-IV (K-WAIS-IV)</title>
        <description>The K-WAIS-IV consists of an assessment of the cognitive ability using a core battery of 10 unique subtests (Block Design, Similarities, Digit Span, Matrix Reasoning, Vocabulary, Arithmetic, Symbol Search, Visual Puzzles, Information, and Coding) that focus on four specific domains of intelligence: verbal comprehension, perceptual reasoning, working memory, and processing speed. The Verbal Comprehension Index, Perceptual Reasoning Index, Working Memory Index, and Processing Speed Index (standard scores: mean=100, standard deviation=15) that are all based on a number of core and supplemental subtests (scaled scores: mean=15, standard deviation=3) that provide pertinent clinical information and flexibility in implementation. The higher values represent a better outcome.</description>
        <time_frame>Part A: Day 1; Part B: Day 7</time_frame>
        <population>All subjects who received at least one dose</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 - 10 mg (Part A)</title>
            <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 - 30 mg (Part A)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 - 100mg (Part A)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 200mg (Part A)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 - 400mg (Part A)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
            <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O7">
            <title>Placebo (Part A)</title>
            <description>12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O8">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O9">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O10">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O11">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O12">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O13">
            <title>Placebo (Part B)</title>
            <description>10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Korean Wechsler Adult Intelligence Scale-IV (K-WAIS-IV)</title>
          <description>The K-WAIS-IV consists of an assessment of the cognitive ability using a core battery of 10 unique subtests (Block Design, Similarities, Digit Span, Matrix Reasoning, Vocabulary, Arithmetic, Symbol Search, Visual Puzzles, Information, and Coding) that focus on four specific domains of intelligence: verbal comprehension, perceptual reasoning, working memory, and processing speed. The Verbal Comprehension Index, Perceptual Reasoning Index, Working Memory Index, and Processing Speed Index (standard scores: mean=100, standard deviation=15) that are all based on a number of core and supplemental subtests (scaled scores: mean=15, standard deviation=3) that provide pertinent clinical information and flexibility in implementation. The higher values represent a better outcome.</description>
          <population>All subjects who received at least one dose</population>
          <units>Intelligence quotient (IQ)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, 3 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="10.05"/>
                    <measurement group_id="O2" value="-0.3" spread="8.73"/>
                    <measurement group_id="O3" value="-3.8" spread="16.18"/>
                    <measurement group_id="O4" value="2.2" spread="8.04"/>
                    <measurement group_id="O5" value="4.8" spread="6.94"/>
                    <measurement group_id="O6" value="3.3" spread="5.24"/>
                    <measurement group_id="O7" value="2.5" spread="8.87"/>
                    <measurement group_id="O8" value="1.7" spread="5.50"/>
                    <measurement group_id="O9" value="4.3" spread="6.41"/>
                    <measurement group_id="O10" value="2.0" spread="15.12"/>
                    <measurement group_id="O11" value="1.2" spread="4.09"/>
                    <measurement group_id="O12" value="1.2" spread="4.45"/>
                    <measurement group_id="O13" value="-1.6" spread="16.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 6 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="14.53"/>
                    <measurement group_id="O2" value="-1.7" spread="8.07"/>
                    <measurement group_id="O3" value="2.7" spread="8.43"/>
                    <measurement group_id="O4" value="8.7" spread="9.79"/>
                    <measurement group_id="O5" value="6.0" spread="8.88"/>
                    <measurement group_id="O6" value="3.3" spread="7.50"/>
                    <measurement group_id="O7" value="3.3" spread="7.97"/>
                    <measurement group_id="O8" value="3.7" spread="6.50"/>
                    <measurement group_id="O9" value="4.7" spread="3.72"/>
                    <measurement group_id="O10" value="2.2" spread="7.22"/>
                    <measurement group_id="O11" value="0.0" spread="16.69"/>
                    <measurement group_id="O12" value="5.5" spread="4.97"/>
                    <measurement group_id="O13" value="2.9" spread="13.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 12 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" spread="14.95"/>
                    <measurement group_id="O2" value="4.5" spread="7.82"/>
                    <measurement group_id="O3" value="3.0" spread="14.99"/>
                    <measurement group_id="O4" value="10.2" spread="10.34"/>
                    <measurement group_id="O5" value="9.5" spread="7.66"/>
                    <measurement group_id="O6" value="7.3" spread="5.82"/>
                    <measurement group_id="O7" value="4.4" spread="12.62"/>
                    <measurement group_id="O8" value="12.7" spread="10.39"/>
                    <measurement group_id="O9" value="13.2" spread="4.26"/>
                    <measurement group_id="O10" value="11.2" spread="7.66"/>
                    <measurement group_id="O11" value="-1.4" spread="10.21"/>
                    <measurement group_id="O12" value="7.0" spread="5.33"/>
                    <measurement group_id="O13" value="6.2" spread="19.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O8" value="10.5" spread="10.33"/>
                    <measurement group_id="O9" value="22.2" spread="13.29"/>
                    <measurement group_id="O10" value="17.6" spread="6.77"/>
                    <measurement group_id="O11" value="11.0" spread="8.72"/>
                    <measurement group_id="O12" value="10.3" spread="5.57"/>
                    <measurement group_id="O13" value="7.3" spread="19.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, 3 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O8" value="15.8" spread="13.88"/>
                    <measurement group_id="O9" value="19.7" spread="6.74"/>
                    <measurement group_id="O10" value="24.6" spread="10.41"/>
                    <measurement group_id="O11" value="12.2" spread="9.76"/>
                    <measurement group_id="O12" value="10.2" spread="5.12"/>
                    <measurement group_id="O13" value="6.6" spread="21.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, 6 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O8" value="13.7" spread="21.16"/>
                    <measurement group_id="O9" value="27.2" spread="6.21"/>
                    <measurement group_id="O10" value="22.0" spread="16.32"/>
                    <measurement group_id="O11" value="14.8" spread="12.03"/>
                    <measurement group_id="O12" value="12.3" spread="5.39"/>
                    <measurement group_id="O13" value="13.6" spread="22.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, 12 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                    <count group_id="O12" value="6"/>
                    <count group_id="O13" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O8" value="17.8" spread="20.94"/>
                    <measurement group_id="O9" value="30.3" spread="12.48"/>
                    <measurement group_id="O10" value="24.4" spread="9.29"/>
                    <measurement group_id="O11" value="18.8" spread="8.26"/>
                    <measurement group_id="O12" value="11.7" spread="3.78"/>
                    <measurement group_id="O13" value="12.8" spread="20.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alpha Synuclein Oligomer in Plasma and CSF (Part B)</title>
        <description>To evaluate Alpha synuclein oligomer in plasma and CSF of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>Plasma - Part B: Day 7 (at 1 hour after last dosing) / CSF - Part B: Day 7 (at 1 hour after last dosing)</time_frame>
        <population>All subjects who received at least one dose in Part B</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours</description>
          </group>
          <group group_id="O4">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>Placebo (Part B)</title>
            <description>10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Alpha Synuclein Oligomer in Plasma and CSF (Part B)</title>
          <description>To evaluate Alpha synuclein oligomer in plasma and CSF of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose in Part B</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CSF, Day 7, 1 hour postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.9424" lower_limit="1.118" upper_limit="188.833"/>
                    <measurement group_id="O2" value="-252.5578" lower_limit="-1565.068" upper_limit="47.610"/>
                    <measurement group_id="O3" value="0.6012" lower_limit="-25.141" upper_limit="24.998"/>
                    <measurement group_id="O4" value="18.2112" lower_limit="-121.943" upper_limit="163.679"/>
                    <measurement group_id="O5" value="34.8672" lower_limit="-22.683" upper_limit="95.017"/>
                    <measurement group_id="O6" value="20.3025" lower_limit="-82.488" upper_limit="145.654"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma, Day 7, 1 hour postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3884.4127" lower_limit="-40474.448" upper_limit="47672.249"/>
                    <measurement group_id="O2" value="575.4570" lower_limit="-29995.002" upper_limit="27948.723"/>
                    <measurement group_id="O3" value="3809.5090" lower_limit="-16201.393" upper_limit="18993.995"/>
                    <measurement group_id="O4" value="-64843.287" lower_limit="-297443.64" upper_limit="4664.264"/>
                    <measurement group_id="O5" value="-11712.090" lower_limit="-45482.537" upper_limit="880.845"/>
                    <measurement group_id="O6" value="-4464.9082" lower_limit="-24410.549" upper_limit="23915.230"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Total Tau in CSF (Part B)</title>
        <description>To evaluate Total Tau in CSF of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>CSF - Part B: Day 1 (at -120 minutes to 0 minute prior to the first dosing) and on Day 7 (at 1 hour after last dosing)</time_frame>
        <population>All subjects who received at least one dose in Part B</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours</description>
          </group>
          <group group_id="O4">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>Placebo (Part B)</title>
            <description>10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Total Tau in CSF (Part B)</title>
          <description>To evaluate Total Tau in CSF of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose in Part B</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.3043" lower_limit="-23.213" upper_limit="145.209"/>
                    <measurement group_id="O2" value="9.2313" lower_limit="-9.048" upper_limit="33.901"/>
                    <measurement group_id="O3" value="-3.1593" lower_limit="-15.058" upper_limit="22.546"/>
                    <measurement group_id="O4" value="27.8648" lower_limit="-32.813" upper_limit="134.771"/>
                    <measurement group_id="O5" value="29.2961" lower_limit="-52.079" upper_limit="203.508"/>
                    <measurement group_id="O6" value="20.8198" lower_limit="-13.358" upper_limit="82.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Phospho-Tau in CSF (Part B)</title>
        <description>To evaluate Phospho-Tau of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
        <time_frame>CSF - Part B: Day 1 (at -120 minutes to 0 minute prior to the first dosing) and on Day 7 (at 1 hour after last dosing)</time_frame>
        <population>All subjects who received at least one dose in Part B</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 30 mg (Part B)</title>
            <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O3">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours</description>
          </group>
          <group group_id="O4">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O5">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O6">
            <title>Placebo (Part B)</title>
            <description>10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Phospho-Tau in CSF (Part B)</title>
          <description>To evaluate Phospho-Tau of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.</description>
          <population>All subjects who received at least one dose in Part B</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4132" lower_limit="-13.590" upper_limit="42.811"/>
                    <measurement group_id="O2" value="0.2072" lower_limit="-1.154" upper_limit="2.231"/>
                    <measurement group_id="O3" value="4.4672" lower_limit="-1.534" upper_limit="18.292"/>
                    <measurement group_id="O4" value="6.7032" lower_limit="-2.773" upper_limit="19.666"/>
                    <measurement group_id="O5" value="5.1606" lower_limit="-5.717" upper_limit="23.325"/>
                    <measurement group_id="O6" value="5.3123" lower_limit="-3.592" upper_limit="23.931"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ratio of CSF Concentration/Plasma Cmax (Part B)</title>
        <description>Ratio of CSF concentration/Plasma Cmax</description>
        <time_frame>Plasma - Part B: Day 7 (at 1 hour after last dosing) / CSF - Part B: on Day 7 (at 1 hour after last dosing)</time_frame>
        <population>All subjects who received at least one dose in Part B</population>
        <group_list>
          <group group_id="O1">
            <title>KM-819 100 mg (Part B)</title>
            <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>KM-819 200mg (Part B)</title>
            <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours</description>
          </group>
          <group group_id="O3">
            <title>KM-819 400mg (Part B)</title>
            <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
          <group group_id="O4">
            <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
            <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of CSF Concentration/Plasma Cmax (Part B)</title>
          <description>Ratio of CSF concentration/Plasma Cmax</description>
          <population>All subjects who received at least one dose in Part B</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00067004" lower_limit="0.00040485" upper_limit="0.00085699"/>
                    <measurement group_id="O2" value="0.00074179" lower_limit="0.00047881" upper_limit="0.00090404"/>
                    <measurement group_id="O3" value="0.00048832" lower_limit="0.00011022" upper_limit="0.0013316"/>
                    <measurement group_id="O4" value="0.00031749" lower_limit="0.00018612" upper_limit="0.00045000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.</time_frame>
      <desc>An AE is any untoward medical occurrence that occurs in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo (Part A)</title>
          <description>12 subjects received placebo orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="E2">
          <title>KM-819 - 10 mg (Part A)</title>
          <description>6 subjects in this cohort received 10 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="E3">
          <title>KM-819 - 30 mg (Part A)</title>
          <description>6 subjects in this cohort received 30 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="E4">
          <title>KM-819 - 100mg (Part A)</title>
          <description>6 subjects in this cohort received 100 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="E5">
          <title>KM-819 200mg (Part A)</title>
          <description>6 subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="E6">
          <title>KM-819 - 400mg (Part A)</title>
          <description>6 subjects in this cohort received 400 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="E7">
          <title>KM-819 200mg (Elderly Male Subjects) (Part A)</title>
          <description>6 elderly male subjects in this cohort received 200 mg of KM-819 orally with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="E8">
          <title>Placebo (Part B)</title>
          <description>10 subjects received placebo of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="E9">
          <title>KM-819 30 mg (Part B)</title>
          <description>6 subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="E10">
          <title>KM-819 100 mg (Part B)</title>
          <description>6 subjects in this cohort received 100 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="E11">
          <title>KM-819 200mg (Part B)</title>
          <description>6 subjects in this cohort received 200 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="E12">
          <title>KM-819 400mg (Part B)</title>
          <description>6 subjects in this cohort received 400 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
        <group group_id="E13">
          <title>KM-819 200mg (Elderly Male Subjects) (Part B)</title>
          <description>6 elderly male subjects in this cohort received 30 mg of KM-819 orally on Day 2 to Day 6, the study drug was administered with approximately 240 mL of water (room temperature), after an overnight fasting for a minimum of 8 hours.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <description>1 patient had a headache which was considered unlikely to be related to KM-819, and probably related to the lumbar puncture procedure.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="6" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Erythema of eyelid</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" events="5" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Face injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" events="3" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Muscle haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E8" events="4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E9" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" events="11" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E12" events="7" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. JaeMoon Lee</name_or_title>
      <organization>Kainos Medicine, Inc</organization>
      <phone>+1 408 202 4017</phone>
      <email>jlee@kainosmedicine.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03022799
org study id: KMCP-819-K101
nct id: NCT03022799
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This first in human, single-center, randomized, placebo-controlled, double blind, sequential
      group Phase 1 study in healthy subjects will be conducted to evaluate the safety,
      tolerability, PK, and PD following the escalation of single and multiple doses of KM-819.

      The study will consist of 2 parts. In Part A, up to 5 cohorts of young adult male subjects,
      and 1 single dose cohort of elderly male or post menopausal female subjects will receive
      escalating single doses of KM-819. In Part B, up to 4 cohorts of healthy young adult male
      subjects and 1 multiple dose cohort of elderly male or post menopausal female subjects will
      receive escalating multiple doses of KM-819. Part B will be conducted after completion of all
      cohorts of young adult male subjects in Part A.

      Dose escalation to the next level will be determined using safety, tolerability, and PK data
      of the previous cohort.

      Part A, Single Ascending Dose (SAD) Up to 40 healthy young adult male subjects and 8 healthy
      elderly male or post menopausal female subjects will be enrolled and randomized to receive
      either KM-819 or placebo.

      Each of the 5 dose escalation cohorts consists of 8 healthy young adult male subjects; 6
      subjects will receive 10, 30, 100, 200, or 400 mg of KM-819 and 2 subjects will receive
      placebo. In each single dose cohort, dosing of subjects will be sentinel, i.e., 2 subjects
      will be dosed on the first day (1 subject will receive active treatment and 1 subject will
      receive placebo) and the remaining 6 subjects will be dosed at least 24 hours after the first
      2 subjects.

      Cohorts will be dosed sequentially with escalating doses. Eight elderly male or
      post-menopausal female subjects will be enrolled into an additional cohort; 6 subjects will
      receive 200 mg KM-819 and 2 subjects will receive placebo.

      Part A consists of a Screening period of up to 28 days, and a 3 day Confinement period when
      subjects are hospitalized for study activities. Subjects are required to return for
      outpatient visits on Day 4, 7 and for the Follow up Visit on Day 14.

      Part B, Multiple Ascending Dose (MAD) Up to 32 healthy young adult male subjects and 8
      healthy elderly male or post menopausal female subjects will be enrolled and randomized to
      receive either KM-819 or placebo.

      Each of the 4 dose escalation cohorts consists of 8 healthy young adult male subjects; 6
      subjects will receive 30, 100, 200, or 400 mg of KM-819 once a day (QD) for 7 days and 2
      subjects will receive placebo. Cohorts will be dosed sequentially with escalating doses.

      Eight elderly male or post-menopausal female subjects will be enrolled into an additional
      cohort; 6 subjects will receive 200 mg KM-819 QD for 7 days and 2 subjects will receive
      placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Adverse Events
time frame: From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.
description: All AEs will be coded using the latest available version 19.1 of the Medical Dictionary for Regulatory Activities (MedDRA).
A treatment-emergent adverse event (TEAE) is defined as an AE that begins or that worsens in severity after at least one dose of the study drug has been administered.
measure: Cmax (Maximum Plasma Concentration Determined Directly From the Concentration-time Profile)
time frame: Part A: Day1 to Day 4. Part B: Day-1 to Day 8
description: To evaluate Cmax of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
measure: Tmax (Time to Achieve Maximum Observed Plasma Concentration Determined Directly From the Concentration-time Profile)
time frame: Part A:Day 1 to 4; Part B: Day 1 to Day 8
description: To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
measure: t½ (Apparent Terminal Elimination Half Life)
time frame: Part A: Day 1 to Day 4. Part B: Day1 to Day 8
description: To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects. To evaluate the PK and PD of single and multiple oral doses of KM-819 in elderly male subjects.
measure: Tlag (Lag Time)
time frame: Part A: Day1 to Day 4. Part B: Day 1 to Day 8
description: To evaluate the T lag of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
measure: AUClast (Area Under the Plasma Concentration-time From Predose (Time 0) to the Last Quantifiable Concentration)
time frame: Part A: Day 1 to 4; Part B: Day 1 to Day 8
description: To evaluate AUClast of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
measure: AUCinf (Area Under the Plasma Concentration-time Curve From Predose (Time 0) Extrapolated to Infinity)
time frame: Part A: Day 1 to 4; Part B: Day 1 to Day 8
description: To evaluate AUCinf of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male-subjects.
measure: %AUCex (Percentage of AUCinf That is Due to Extrapolation Beyond Tlast)
time frame: Part A: Day 1 to 4; Part B: Day 1 to Day 8
description: To evaluate %AUCex of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
measure: CL/F (Apparent Oral Clearance)
time frame: Part A: Day 1 to 4; Part B: Day 1 to Day 8
description: To evaluate the CL/F of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
measure: Vz/F (Apparent Volume of Distribution)
time frame: Part A: Day 1 to 4; Part B: Day 1 to Day 8
description: To evaluate Vz/F of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.
measure: AUCtau (Area Under the Plasma Concentration-time Curve for a Dosing Interval) (Part B)
time frame: Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,
description: To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.
measure: Rac(AUC) (Observed Accumulation by AUC) (Part B)
time frame: Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,
description: To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.
measure: Rac (Cmax) (Observed Accumulation by Cmax) (Part B)
time frame: Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,
description: To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
measure: AUCtau_D (AUCtau Divided by Dose) (Part B)
time frame: Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,
description: To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
measure: Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)
time frame: At Day 1 (3 hours post dose), Day2, Day 3, Day 4, and Day 8.
description: The Bond-Lader Visual Analogue Scales (VAS) will be analyzed using 3 factor scores: alertness, contentedness, and calmness. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered. Baseline is defined as the last available recording prior to dosing on Day 1.
Alertness (Range 0 to 100, the higher scores indicated more alertness)
Mood (Range 0 to 100, where higher scores indicated elevated mood)
Calmness (Range 0 to 100, where higher scores indicated more calmness).
measure: Korean Wechsler Adult Intelligence Scale-IV (K-WAIS-IV)
time frame: Part A: Day 1; Part B: Day 7
description: The K-WAIS-IV consists of an assessment of the cognitive ability using a core battery of 10 unique subtests (Block Design, Similarities, Digit Span, Matrix Reasoning, Vocabulary, Arithmetic, Symbol Search, Visual Puzzles, Information, and Coding) that focus on four specific domains of intelligence: verbal comprehension, perceptual reasoning, working memory, and processing speed. The Verbal Comprehension Index, Perceptual Reasoning Index, Working Memory Index, and Processing Speed Index (standard scores: mean=100, standard deviation=15) that are all based on a number of core and supplemental subtests (scaled scores: mean=15, standard deviation=3) that provide pertinent clinical information and flexibility in implementation. The higher values represent a better outcome.
measure: Alpha Synuclein Oligomer in Plasma and CSF (Part B)
time frame: Plasma - Part B: Day 7 (at 1 hour after last dosing) / CSF - Part B: Day 7 (at 1 hour after last dosing)
description: To evaluate Alpha synuclein oligomer in plasma and CSF of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
measure: Change From Baseline Total Tau in CSF (Part B)
time frame: CSF - Part B: Day 1 (at -120 minutes to 0 minute prior to the first dosing) and on Day 7 (at 1 hour after last dosing)
description: To evaluate Total Tau in CSF of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
measure: Change From Baseline Phospho-Tau in CSF (Part B)
time frame: CSF - Part B: Day 1 (at -120 minutes to 0 minute prior to the first dosing) and on Day 7 (at 1 hour after last dosing)
description: To evaluate Phospho-Tau of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.
measure: Ratio of CSF Concentration/Plasma Cmax (Part B)
time frame: Plasma - Part B: Day 7 (at 1 hour after last dosing) / CSF - Part B: on Day 7 (at 1 hour after last dosing)
description: Ratio of CSF concentration/Plasma Cmax
arm group label: KM-819
arm group type: Experimental
description: Each cohort consists of 8 subjects; 6 subjects will receive planned dose of KM-819 and 2 subjects will receive placebo.
arm group label: Placebo
arm group type: Placebo Comparator
description: Each cohort consists of 8 subjects; 6 subjects will receive planned dose of KM-819 and 2 subjects will receive placebo.
intervention type: Drug
intervention name: KM-819
arm group label: KM-819
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jae Moon Lee, PhD
role: Study Director
affiliation: Kainos Medicine Inc.
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: Undecided
ipd description: Individual identifiable personal information will not be shared. All individuals will be coded by a 4-digit study code.
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 