<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/NCT04503863</url>
  </required_header>
  <id_info>
    <org_study_id>NPC-22-2</org_study_id>
    <nct_id>NCT04503863</nct_id>
  </id_info>
  <brief_title>An Additional Study of NPC-22 in Healthy Adult Males</brief_title>
  <official_title>Additional Phase 1 Study of NPC-22 for High Dosage in Healthy Adult Males</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nobelpharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nobelpharma</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>
      The purpose of this study is to examine the safety and pharmacokinetics of high dose NPC-22&#xD;
      administration in healthy adult males.&#xD;
&#xD;
      The effect of administration routes for pharmacokinetics will be examined in advance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">December 28, 2021</completion_date>
  <primary_completion_date type="Actual">November 6, 2020</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>Sequential Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>0-14 days post dose</time_frame>
    <description>An adverse event will refer to any unfavorable or unintended sign (including an abnormal laboratory finding and abnormality on the 12-lead ECG or in vital signs) and symptom</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body temperature</measure>
    <time_frame>0-14 days post dose</time_frame>
    <description>Body temperature will be measured for assess the safety of single ascending dose of NPC-22</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>0-14 days post dose</time_frame>
    <description>Blood pressure will be measured for assess the safety of single ascending dose of NPC-22</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse rate</measure>
    <time_frame>0-14 days post dose</time_frame>
    <description>Pulse rate will be measured for assess the safety of single ascending dose of NPC-22</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG</measure>
    <time_frame>0-14 days post dose</time_frame>
    <description>RR, PR, QRS, QT and QTcF interval and heart rate will be measured for assess the safety of single ascending dose of NPC-22</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and/or rates of subjects with treatment-related adverse events as assessed by hematology tests</measure>
    <time_frame>0-14 days post dose</time_frame>
    <description>Hematology tests will be performed for assessment the safety of single ascending dose of NPC-22</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and/or rates of subjects with treatment-related adverse events as assessed by blood chemistry tests</measure>
    <time_frame>0-14 days post dose</time_frame>
    <description>Blood chemistry tests will be performed for assessment the safety of single ascending dose of NPC-22</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and/or rates of subjects with treatment-related adverse events as assessed by urinalysis</measure>
    <time_frame>0-14 days post dose</time_frame>
    <description>Urinalysis will be performed for assessment the safety of single ascending dose of NPC-22</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observed plasma concentration</measure>
    <time_frame>0-14 days post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed urine concentration</measure>
    <time_frame>0-14 days post dose</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Safety and Pharmacokinetics</condition>
  <arm_group>
    <arm_group_label>Experimental 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single administration of middle dose NPC-22</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single administration of high dose NPC-22</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental 3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single administration of placebo dose NPC-22</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NPC-22</intervention_name>
    <description>Single administration of middle dose NPC-22</description>
    <arm_group_label>Experimental 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NPC-22</intervention_name>
    <description>Single administration of high dose NPC-22</description>
    <arm_group_label>Experimental 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NPC-22 Placebo</intervention_name>
    <description>Single administration of NPC-22 Placebo</description>
    <arm_group_label>Experimental 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Japanese individuals who have been confirmed to meet all of the following criteria will be&#xD;
        enrolled as a subject:&#xD;
&#xD;
          1. Individuals who have provided their own written informed consent&#xD;
&#xD;
          2. Individuals aged ≥20 and &lt;40 years at the time of informed consent&#xD;
&#xD;
          3. Individuals with body weight of ≥50 kg and body mass index (BMI) (kg/m2) of ≥18.5 and&#xD;
             &lt;25.0&#xD;
&#xD;
          4. Individuals who were identified to have no health problem on physical examination,&#xD;
             physical assessment, laboratory tests, or other examinations at screening by the&#xD;
             principal investigator or a sub-investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Japanese Individuals who meet any of the following criteria will be excluded from the&#xD;
        study:&#xD;
&#xD;
          1. Individuals who are suffering or have a history of any skin disease or skin&#xD;
             abnormality at the site of study drug administration (postauricular region, breast,&#xD;
             upper arm and abdomen) that may prevent evaluation or are receiving treatment at the&#xD;
             site of study drug administration that may prevent evaluation (e.g., topical&#xD;
             corticosteroids)&#xD;
&#xD;
          2. Individuals who are hypersensitive to scopolamine or atropine (belladonna alkaloid) or&#xD;
             have a complication or a history of drug allergy&#xD;
&#xD;
          3. Individuals with a complication or a history of drug abuse (use of an illicit drug) or&#xD;
             alcohol dependence&#xD;
&#xD;
          4. Individuals with a history of severe disease that may recur during the study period&#xD;
&#xD;
          5. Individuals with any concurrent illnesses (including symptoms and findings, however&#xD;
             excluding diseases that will not affect study evaluations such as pollinosis without&#xD;
             manifestations and verruca)&#xD;
&#xD;
          6. Individuals who received another study drug within 180 days prior to the start of&#xD;
             study drug administration&#xD;
&#xD;
          7. Individuals who donated blood of ≥400 mL within 12 weeks, blood of ≥200 mL within 4&#xD;
             weeks, or blood components within 2 weeks prior to the start of the study&#xD;
&#xD;
          8. Individuals who used any medicinal product (including over the counter drugs except&#xD;
             for topical products) or similar product like a dietary supplement (including health&#xD;
             food) within 7 days prior to the start of study drug administration&#xD;
&#xD;
          9. Individuals who took any food or beverage containing grapefruit or St. John's wort&#xD;
             within 7 days prior to the start of study drug administration&#xD;
&#xD;
         10. Individuals who took any alcohol or caffeine-containing beverage within 3 days prior&#xD;
             to the start of study drug administration&#xD;
&#xD;
         11. Individuals who smoked (used a product such as a cigarette, pipe, cigar, chewing&#xD;
             tobacco, electronic cigarette, nicotine patch, or nicotine gum) within 90 days prior&#xD;
             to the start of study drug administration, or do not agree to stop smoking during the&#xD;
             study period&#xD;
&#xD;
         12. Individuals who had a positive result for HBs antigen, HCV antibody, or HIV&#xD;
             antigen/antibody, or a positive reaction to syphilis serology or urine drug test at&#xD;
             screening&#xD;
&#xD;
         13. Individuals who are unsuitable as a subject in this study in the judgement of the&#xD;
             principal investigator or a sub-investigator based on the 12-lead electrocardiogram at&#xD;
             screening [e.g., Fridericia's corrected QT (QTcF) interval of ≥450 ms]&#xD;
&#xD;
         14. Individuals who have serum electrolyte levels (potassium, calcium, and magnesium)&#xD;
             lower than the institutional reference values&#xD;
&#xD;
         15. Individuals who have a familial history of torsades de pointes or long QT syndrome&#xD;
&#xD;
         16. Individuals who had blood pressure, pulse rate, or body temperature at screening as&#xD;
             specified below [1]Systolic blood pressure: &lt;90 mmHg or ≥140 mmHg [2]Diastolic blood&#xD;
             pressure: &lt;40 mmHg or ≥90 mmHg [3]Pulse rate: &lt;50 beats/min or ≥100 beats/min [4]Body&#xD;
             temperature: &lt;35.0°C or ≥37.1°C&#xD;
&#xD;
         17. Individuals who are unsuitable as a subject in this study in the judgement of the&#xD;
             principal investigator or a sub-investigator by having a deviation from the&#xD;
             institutional reference values&#xD;
&#xD;
         18. Individuals who are unsuitable as a subject in this study in the judgement of the&#xD;
             principal investigator or a sub-investigator due to other reasons&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical Corporation Shinanokai Shinanozaka Clinic</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Tokyo</state>
        <zip>160-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>February 4, 2022</last_update_submitted>
  <last_update_submitted_qc>February 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04503863
org study id: NPC-22-2
nct id: NCT04503863
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the safety and pharmacokinetics of high dose NPC-22
      administration in healthy adult males.

      The effect of administration routes for pharmacokinetics will be examined in advance.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse events
time frame: 0-14 days post dose
description: An adverse event will refer to any unfavorable or unintended sign (including an abnormal laboratory finding and abnormality on the 12-lead ECG or in vital signs) and symptom
measure: Body temperature
time frame: 0-14 days post dose
description: Body temperature will be measured for assess the safety of single ascending dose of NPC-22
measure: Blood pressure
time frame: 0-14 days post dose
description: Blood pressure will be measured for assess the safety of single ascending dose of NPC-22
measure: Pulse rate
time frame: 0-14 days post dose
description: Pulse rate will be measured for assess the safety of single ascending dose of NPC-22
measure: ECG
time frame: 0-14 days post dose
description: RR, PR, QRS, QT and QTcF interval and heart rate will be measured for assess the safety of single ascending dose of NPC-22
measure: Number and/or rates of subjects with treatment-related adverse events as assessed by hematology tests
time frame: 0-14 days post dose
description: Hematology tests will be performed for assessment the safety of single ascending dose of NPC-22
measure: Number and/or rates of subjects with treatment-related adverse events as assessed by blood chemistry tests
time frame: 0-14 days post dose
description: Blood chemistry tests will be performed for assessment the safety of single ascending dose of NPC-22
measure: Number and/or rates of subjects with treatment-related adverse events as assessed by urinalysis
time frame: 0-14 days post dose
description: Urinalysis will be performed for assessment the safety of single ascending dose of NPC-22
measure: Observed plasma concentration
time frame: 0-14 days post dose
measure: Observed urine concentration
time frame: 0-14 days post dose
arm group label: Experimental 1
arm group type: Experimental
description: Single administration of middle dose NPC-22
arm group label: Experimental 2
arm group type: Experimental
description: Single administration of high dose NPC-22
arm group label: Experimental 3
arm group type: Placebo Comparator
description: Single administration of placebo dose NPC-22
intervention type: Drug
intervention name: NPC-22
description: Single administration of middle dose NPC-22
arm group label: Experimental 1
intervention type: Drug
intervention name: NPC-22
description: Single administration of high dose NPC-22
arm group label: Experimental 2
intervention type: Drug
intervention name: NPC-22 Placebo
description: Single administration of NPC-22 Placebo
arm group label: Experimental 3
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Japan
responsible party type: Sponsor
sharing ipd: Undecided