<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/NCT02243683</url>
  </required_header>
  <id_info>
    <org_study_id>AX-024-1.01</org_study_id>
    <nct_id>NCT02243683</nct_id>
  </id_info>
  <brief_title>Safety Study of Immune System Modulator for Autoimmune Diseases</brief_title>
  <official_title>A Randomized, Placebo Controlled, Double Blind, Dose Escalating, Crossover, Safety and Pharmacokinetic Study of AX-024.HCl in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Artax Biopharma Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Simbec Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>ORION Clinical Services</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Packaging Coordinators Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro de Biología Molecular Severo Ochoa, Spain (CBMSO)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Artax Biopharma Inc</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the toxicity, tolerability and safety of single&#xD;
      ascending doses of AX-024.HCl in healthy male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Crossover Assignment</intervention_model>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Serious and Non-Serious Adverse Events</measure>
    <time_frame>Over a 72 hours period and 7 days after last dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-Time Curve</measure>
    <time_frame>Over a 72 hours period post dose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AX-024.HCl</intervention_name>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_label>Cohort B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_label>Cohort B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with a body mass index (BMI) of 18 - 35 kg/m2, inclusive. BMI = Body weight&#xD;
             (kg) / [Height (m)]2.&#xD;
&#xD;
          -  In good health as determined by medical history, physical examination, and clinical&#xD;
             judgment of the investigator&#xD;
&#xD;
          -  Subject with no history of autoimmune disease or cardiac disease&#xD;
&#xD;
          -  Subjects must be available to complete the study (including follow-up visit).&#xD;
&#xD;
          -  Subjects must satisfy a medical examiner about their fitness to participate in the&#xD;
             study.&#xD;
&#xD;
          -  Subjects must provide written informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A clinically significant history of gastrointestinal disorder likely to influence drug&#xD;
             absorption.&#xD;
&#xD;
          -  Receipt of regular medication within 21 days of the first dose that may have an impact&#xD;
             on the safety and objectives of the study (at the Investigator's discretion).&#xD;
&#xD;
          -  Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or&#xD;
             metabolic dysfunction.&#xD;
&#xD;
          -  Subjects who are smokers, or ex-smokers who have smoked in the last 3 months&#xD;
             (determined by negative urine cotinine at screening visit).&#xD;
&#xD;
          -  A clinically significant history of hypersensitivity (anaphylaxis, angioedema) to any&#xD;
             drug.&#xD;
&#xD;
          -  A clinically significant history of drug or alcohol abuse.&#xD;
&#xD;
          -  Participation in a New Chemical Entity clinical study within the previous 4 months or&#xD;
             a marketed drug clinical study within the previous 3 months. (N.B. washout period&#xD;
             between studies is defined as the period of time elapsed between the last dose of the&#xD;
             previous study and the first dose of the next study).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Girish Sharma, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Simbec Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Simbec Research Ltd</name>
      <address>
        <city>Merthyr Tydfil</city>
        <state>Cardiff Road</state>
        <zip>CF48 4DR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>October 13, 2015</last_update_submitted>
  <last_update_submitted_qc>October 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT02243683
org study id: AX-024-1.01
nct id: NCT02243683
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
The purpose of this study is to determine the toxicity, tolerability and safety of single
      ascending doses of AX-024.HCl in healthy male subjects.
allocation: Randomized
intervention model: Crossover Assignment
masking: Double (Participant, Investigator)
measure: Number of Participants with Serious and Non-Serious Adverse Events
time frame: Over a 72 hours period and 7 days after last dose
measure: Area Under the Concentration-Time Curve
time frame: Over a 72 hours period post dose
arm group label: Cohort A
arm group type: Experimental
description: Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo
arm group label: Cohort B
arm group type: Experimental
description: Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo
intervention type: Drug
intervention name: AX-024.HCl
arm group label: Cohort A
arm group label: Cohort B
intervention type: Other
intervention name: Placebo
arm group label: Cohort A
arm group label: Cohort B
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Girish Sharma, MBBS
role: Principal Investigator
affiliation: Simbec Research
facility: 
country: United Kingdom
responsible party type: Sponsor