<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/NCT04464681</url>
  </required_header>
  <id_info>
    <org_study_id>M201-A-CT-003</org_study_id>
    <nct_id>NCT04464681</nct_id>
  </id_info>
  <brief_title>Multiple Dose Escalation Study of M201-A in Healthy Japanese Subjects</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Multiple Continuous Intravenous Injection, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of M201-A in Healthy Japanese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kitasato University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aetas Pharma Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kitasato University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase I is designed to evaluate the safety, tolerability and pharmacokinetics of&#xD;
      multiple ascending doses of M201-A administered by multiple continuous intravenous injection&#xD;
      in Healthy Japanese subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 28, 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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events as a measure of safety and tolerability</measure>
    <time_frame>Throughout the study duration up to day 11</time_frame>
    <description>Number of participants with adverse events, serious adverse events, physical examinations, vital sign measurements, 12-lead ECGs, Holter ECG, clinical laboratory safety tests (including hematology, chemistry, and urinalysis), recording of concomitant medications and procedures.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>M201-A Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active Substance: M201-A Route of administration: continuous intravenous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo: M201-A Placebo Route of administration: continuous intravenous injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>M201-A Injection</intervention_name>
    <description>Active Substance: M201-A Route of administration: continuous intravenous injection</description>
    <arm_group_label>M201-A Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo: M201-A Placebo Route of administration: continuous intravenous injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must satisfy the following criteria to be enrolled in the study&#xD;
&#xD;
          -  (1)Japanese Healthy Male subjects&#xD;
&#xD;
          -  (2)Age 20 to less than 50 years of age&#xD;
&#xD;
          -  (3)Body Weight of more than 50 kg, Body Mass Index (BMI) of 18.5 to less than 25.0&#xD;
             kg/m2 at the screening examination&#xD;
&#xD;
          -  (4)Written informed consent must be obtained on a voluntary basis before any&#xD;
             assessment is performed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The presence of any of the following will exclude a subject from enrollment:&#xD;
&#xD;
          -  (1)Presence or past medical history of hepatic impairments, renal impairments,&#xD;
             cardiovascular disease, gastrointestinal disease and others which are inappropriate&#xD;
             for participating in this clinical trial&#xD;
&#xD;
          -  (2)Past medical history of cancer, cerebral infarction or cardiac infarction&#xD;
&#xD;
          -  (3)Past history of surgical operation of gastrointestine or kidney except appendectomy&#xD;
             or hemorrhoid operation.&#xD;
&#xD;
          -  (4)Presence or past history of epilepsy.&#xD;
&#xD;
          -  (5)Presence or past medical history of allergic reactions or idiosyncrasies to food,&#xD;
             medicinal substance and metallic materials&#xD;
&#xD;
          -  (6)heart rate(HR) &gt;= 100 bpm at the screening examination&#xD;
&#xD;
          -  (7)The corrected QT interval(QTcF) &gt;= 440 ms at the screening examination&#xD;
&#xD;
          -  (8)brain natriuretic peptide(BNP) &gt; 40 pg/mL at the screening examination&#xD;
&#xD;
          -  (9)K&lt;3.6 mEq/L at the screening examination&#xD;
&#xD;
          -  (10)Past history or suspect of aldosteronism.&#xD;
&#xD;
          -  (11)Any risk factors of Torsades de Pointes including such as heart failure,&#xD;
             hypokalemia, long QT interval syndrome due to family medical history&#xD;
&#xD;
          -  (12)Cre&gt;1.10 mg/dL, &lt;0.85 mg/dL at the screening examination&#xD;
&#xD;
          -  (13)Subject who donated whole blood of 400 mL within 12 weeks or whole blood of 400 mL&#xD;
             of 200 mL / blood component donation within 4weeks prior to the first administration.&#xD;
&#xD;
          -  (14)Use of prescription drug, over-the-counter medications (except eye drops for&#xD;
             dryness, sanitizer for preventing infection), or herbal medication within 4 weeks&#xD;
             prior to study medication.&#xD;
&#xD;
          -  (15)Subject who consumed furanocoumarin containing food within 7 days prior to study&#xD;
             medication.&#xD;
&#xD;
          -  (16)Subject who drunk alcohol or caffeine containing drink within 3 days prior to&#xD;
             study medication.&#xD;
&#xD;
          -  (17)Subject who was administered of another investigational drug within16 weeks prior&#xD;
             to agree to participate in this study.&#xD;
&#xD;
          -  (18)Subject who was administered M201-A in the past.&#xD;
&#xD;
          -  (19)Subject who smoke within 90 day prior to study medication or who cannot quit&#xD;
             smoking during the study period.&#xD;
&#xD;
          -  (20)Subject with positive result in hepatitis B(HB)s antigen, hepatitis C virus(HCV)&#xD;
             antibody, HIV antigen/antibody, Syphilis serum, urine drug test at the screening test.&#xD;
             Subject with positive result in Coronavirus(COVID-19) test at the screening or at the&#xD;
             hospitalization.&#xD;
&#xD;
          -  (21) Presence or past history of drug/alcohol abuse.&#xD;
&#xD;
          -  (22)Subject who do not use medically acceptable contraceptive method until 90 days&#xD;
             after the final study drug administration.&#xD;
&#xD;
          -  (23)Subject who investigator judges ineligible for other reasons&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Trial Center, Department of Research, KITASATO UNIVERSITY KITASATO INSTITUTE HOSPITAL</name>
      <address>
        <city>Tokyo</city>
        <zip>108-8642</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>August 29, 2021</last_update_submitted>
  <last_update_submitted_qc>August 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kitasato University</investigator_affiliation>
    <investigator_full_name>Tomoko Hasunuma</investigator_full_name>
    <investigator_title>Director of Clinical Trial Center</investigator_title>
  </responsible_party>
  <!-- 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/NCT04464681
org study id: M201-A-CT-003
nct id: NCT04464681
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This Phase I is designed to evaluate the safety, tolerability and pharmacokinetics of
      multiple ascending doses of M201-A administered by multiple continuous intravenous injection
      in Healthy Japanese subjects.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of participants with adverse events as a measure of safety and tolerability
time frame: Throughout the study duration up to day 11
description: Number of participants with adverse events, serious adverse events, physical examinations, vital sign measurements, 12-lead ECGs, Holter ECG, clinical laboratory safety tests (including hematology, chemistry, and urinalysis), recording of concomitant medications and procedures.
arm group label: M201-A Injection
arm group type: Experimental
description: Active Substance: M201-A Route of administration: continuous intravenous injection
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo: M201-A Placebo Route of administration: continuous intravenous injection
intervention type: Drug
intervention name: M201-A Injection
description: Active Substance: M201-A Route of administration: continuous intravenous injection
arm group label: M201-A Injection
intervention type: Drug
intervention name: Placebo
description: Placebo: M201-A Placebo Route of administration: continuous intravenous injection
arm group label: Placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Kitasato University
investigator full name: Tomoko Hasunuma
investigator title: Director of Clinical Trial Center