<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/NCT03830528</url>
  </required_header>
  <id_info>
    <org_study_id>6356-004</org_study_id>
    <nct_id>NCT03830528</nct_id>
  </id_info>
  <brief_title>A Study of Single and Multiple Doses of KW-6356 in Healthy Subjects</brief_title>
  <official_title>A Phase I Study of KW-6356 in Japanese and Caucasian Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyowa Kirin Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyowa Kirin Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</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>
      Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple&#xD;
      doses of KW-6356 in healthy volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will have 3 parts:&#xD;
&#xD;
        -  In Part A and Part B, a placebo-controlled double-blind study will be conducted to&#xD;
           investigate safety, tolerability and pharmacokinetics of a single dose and 14 days&#xD;
           multiple doses of KW-6356 in Japanese healthy men, respectively&#xD;
&#xD;
        -  In Part C, an open-label study will be conducted to investigate safety, tolerability and&#xD;
           pharmacokinetics of 7 days multiple doses of KW-6356 in Japanese and Caucasian healthy&#xD;
           men&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2019</start_date>
  <completion_date type="Actual">October 10, 2019</completion_date>
  <primary_completion_date type="Actual">October 10, 2019</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part A Number and percentage of subjects with treatment-emergent adverse events</measure>
    <time_frame>Starting about 24 hours before dosing and continued until about 7-14 days after last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part B Number and percentage of subjects with treatment-emergent adverse events</measure>
    <time_frame>Starting about 24 hours before dosing and continued until about 7-14 days after last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part C Profiles of pharmacokinetics of plasma KW-6356 concentrations</measure>
    <time_frame>Starting about 24 hours before dosing and continued until about 7-14 days after last dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part A Profiles of pharmacokinetics of plasma KW-6356 concentrations</measure>
    <time_frame>Starting about 24 hours before dosing and continued until about 7-14 days after last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B Profiles of pharmacokinetics of plasma KW-6356 concentrations</measure>
    <time_frame>Starting about 24 hours before dosing and continued until about 7-14 days after last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C Number and percentage of subjects with treatment-emergent adverse events</measure>
    <time_frame>Starting about 24 hours before dosing and continued until about 7-14 days after last dose</time_frame>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Part A-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A-3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There will be one cohort of Japanese healthy men dosed with multiple doses of KW-6356 or placebo and one potential additional cohort (KW-6356 dose as determined in Part A or placebo)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KW-6356 Low Dose</intervention_name>
    <description>KW-6356 will be administered as single doses.</description>
    <arm_group_label>Part A-1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KW-6356 Middle Dose</intervention_name>
    <description>KW-6356 will be administered as single doses.</description>
    <arm_group_label>Part A-2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KW-6356 High Dose</intervention_name>
    <description>KW-6356 will be administered as single doses.</description>
    <arm_group_label>Part A-3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KW-6356 X Dose</intervention_name>
    <description>KW-6356 will be administered as multiple doses.</description>
    <arm_group_label>Part B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KW-6356 Y Dose</intervention_name>
    <description>KW-6356 will be administered for Japanese healthy men as multiple doses.</description>
    <arm_group_label>Part C-1</arm_group_label>
    <arm_group_label>Part C-2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>All study cohorts (except Part C) are placebo controlled.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals who provided freely-given written consent for participating in this study&#xD;
&#xD;
          -  Men aged 20 ≥ and &lt; 45 at the time of informed consent;&#xD;
&#xD;
               -  Japanese individuals without mixed marriage for at least last two generations,&#xD;
                  for participating Part A and Part B&#xD;
&#xD;
               -  Japanese and Caucasian individuals without mixed marriage for at least last two&#xD;
                  generations, for participating Part C&#xD;
&#xD;
          -  Individuals with BMI ≥ 18.5 and &lt; 30.0&#xD;
&#xD;
          -  Individuals with screening results of; resting pulse rate: 40 to 100 bpm, systolic&#xD;
             blood pressure: 91 to 140 mmHg, diastolic blood pressure: 40 to 90 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with any current diseases requiring treatment&#xD;
&#xD;
          -  Individuals with current cerebrovascular, gastrointestinal, cardiovascular,&#xD;
             hematologic, renal, or liver diseases&#xD;
&#xD;
          -  Individuals with current symptomatic allergy&#xD;
&#xD;
          -  Individuals with current or past drug allergy&#xD;
&#xD;
          -  Individuals with current or past psychiatric disorders&#xD;
&#xD;
          -  Individuals with a history of any autoimmune diseases or malignant tumor&#xD;
&#xD;
          -  Individuals with alcohol or drug dependence, or those who showed any positive&#xD;
             result(s) in drug abuse tests&#xD;
&#xD;
          -  Individuals with a history of congestive heart failure, hypokalemia, hypocalcemia, or&#xD;
             QT prolongation syndrome&#xD;
&#xD;
          -  Individuals with positive result in any of viral infection tests (HBs antigen, HBs&#xD;
             antibody, HBc antibody, HCV antibody, HIV antigen and antibody, and HTLV-1 antibody)&#xD;
             or syphilis tests (RPR and TP antibody) at screening.&#xD;
&#xD;
          -  Individuals with abnormality in standard 12-lead ECG that the investigator or&#xD;
             subinvestigator determined as clinically significant at screening, Day -1, and before&#xD;
             administration of the study drug on Day 1.&#xD;
&#xD;
          -  Individuals who participated in clinical trial(s) of any medical products and received&#xD;
             administration of those within 4 months prior to the study drug administration in the&#xD;
             current study&#xD;
&#xD;
          -  Individuals who used drugs (including non-prescription drugs, external preparation,&#xD;
             vitamins, health supplements, and herbal medicines) within 2 weeks prior to the study&#xD;
             drug administration&#xD;
&#xD;
          -  Individuals who consumed grapefruit, or any food and beverage containing grapefruit or&#xD;
             St John's Wort within 1 week prior to the study drug administration&#xD;
&#xD;
          -  Individuals who smoked or used stop-smoking aid products (including chewing or eating&#xD;
             nicotine-containing products, or application of nicotine patches) within 4 weeks prior&#xD;
             to the study drug administration&#xD;
&#xD;
          -  Individuals who admitted to the hospital or had surgery within 3 months prior to the&#xD;
             study drug administration&#xD;
&#xD;
          -  Individuals who had any of the following blood drawing for donation, clinical trial,&#xD;
             or any other reasons prior to the study drug administration; ≥ 400 mL blood collection&#xD;
             within 3 months; ≥ 200 mL blood collection within 4 weeks; or blood collection for&#xD;
             pheresis (such as plasmapheresis or plateletpheresis) donation, clinical trial, or any&#xD;
             other reasons within 2 weeks&#xD;
&#xD;
          -  Individuals who did not agree to use appropriate contraceptive measures from the day&#xD;
             of admission to 12 weeks after the last administration of study drug. The appropriate&#xD;
             contraceptive measures are defined as refraining from sexual activity or combining two&#xD;
             contraceptive methods including condom, oral contraceptives, intrauterine&#xD;
             contraceptive devices or pessary.&#xD;
&#xD;
          -  Any other individuals who were determined as not suitable for participating in this&#xD;
             study by the investigator or subinvestigator&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical Co. LTA Sumida Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>February 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>November 27, 2019</last_update_submitted>
  <last_update_submitted_qc>November 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03830528
org study id: 6356-004
nct id: NCT03830528
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple
      doses of KW-6356 in healthy volunteers
The study will have 3 parts:

        -  In Part A and Part B, a placebo-controlled double-blind study will be conducted to
           investigate safety, tolerability and pharmacokinetics of a single dose and 14 days
           multiple doses of KW-6356 in Japanese healthy men, respectively

        -  In Part C, an open-label study will be conducted to investigate safety, tolerability and
           pharmacokinetics of 7 days multiple doses of KW-6356 in Japanese and Caucasian healthy
           men
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Part A Number and percentage of subjects with treatment-emergent adverse events
time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
measure: Part B Number and percentage of subjects with treatment-emergent adverse events
time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
measure: Part C Profiles of pharmacokinetics of plasma KW-6356 concentrations
time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
measure: Part A Profiles of pharmacokinetics of plasma KW-6356 concentrations
time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
measure: Part B Profiles of pharmacokinetics of plasma KW-6356 concentrations
time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
measure: Part C Number and percentage of subjects with treatment-emergent adverse events
time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
arm group label: Part A-1
arm group type: Experimental
description: There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.
arm group label: Part A-2
arm group type: Experimental
description: There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.
arm group label: Part A-3
arm group type: Experimental
description: There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.
arm group label: Part B
arm group type: Experimental
description: There will be one cohort of Japanese healthy men dosed with multiple doses of KW-6356 or placebo and one potential additional cohort (KW-6356 dose as determined in Part A or placebo)
arm group label: Part C-1
arm group type: Experimental
description: There will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies)
arm group label: Part C-2
arm group type: Experimental
description: There will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies)
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: KW-6356 Low Dose
description: KW-6356 will be administered as single doses.
arm group label: Part A-1
intervention type: Drug
intervention name: KW-6356 Middle Dose
description: KW-6356 will be administered as single doses.
arm group label: Part A-2
intervention type: Drug
intervention name: KW-6356 High Dose
description: KW-6356 will be administered as single doses.
arm group label: Part A-3
intervention type: Drug
intervention name: KW-6356 X Dose
description: KW-6356 will be administered as multiple doses.
arm group label: Part B
intervention type: Drug
intervention name: KW-6356 Y Dose
description: KW-6356 will be administered for Japanese healthy men as multiple doses.
arm group label: Part C-1
arm group label: Part C-2
intervention type: Drug
intervention name: Placebo
description: All study cohorts (except Part C) are placebo controlled.
arm group label: Placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: Undecided