<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/NCT01731275</url>
  </required_header>
  <id_info>
    <org_study_id>E6011-J081-001</org_study_id>
    <nct_id>NCT01731275</nct_id>
  </id_info>
  <brief_title>A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects (Study E6011-J081-001)</brief_title>
  <official_title>A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <brief_summary>
    <textblock>
      To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single&#xD;
      ascending dose (SAD) administration of E6011 in Japanese healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>An Adverse Event (AE) is any untoward medical occurrence in a participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. The investigator or sub-investigator reviews all laboratory findings and determines if they constitute an AE. In-patient observation assessments will be performed during 1 week post-dose, followed by the out-patient observation assessments in groups: 0.0006, 0.006, 0.04, 0.2 mg/kg up to the end of Week 8 and in groups: 1, 3, 6, 10 kg/mg) up to the end of Week 24.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Up to 24 Weeks post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>Up to 24 Weeks post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]</measure>
    <time_frame>Up to 24 Weeks post-dose</time_frame>
    <description>AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)]</measure>
    <time_frame>Up to 24 Weeks post-dose</time_frame>
    <description>AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life (t1/2)</measure>
    <time_frame>Up to 24 Weeks post-dose</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameter: Volume of Distribution (Vd)</measure>
    <time_frame>Up to 24 Weeks post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameter: Clearance (CL)</measure>
    <time_frame>Up to 24 Weeks post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Healthy Male Volunteers</condition>
  <arm_group>
    <arm_group_label>E6011</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>E6011 Matching Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E6011</intervention_name>
    <description>A single ascending dose (SAD) administration of E6011 is administered to 8 groups as a 30-minute intravenous infusion at a dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.</description>
    <arm_group_label>E6011</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E6011 Matching Placebo</intervention_name>
    <description>A SAD administration of E6011 Matching Placebo is administered to 2 participants in each of 8 groups as a 30-minute intravenous infusion at a placebo dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending E6011 Matching Placebo dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.</description>
    <arm_group_label>E6011 Matching Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria;&#xD;
&#xD;
          1. Non-smoking Japanese male subjects aged &gt;= 20 to less than 45 years&#xD;
&#xD;
          2. BMI at screening is &gt;= 18.5 kg/m2 to less than 25.0 kg/m^2&#xD;
&#xD;
          3. Males who have not had a successful vasectomy and their female partners must agree to&#xD;
             practice highly effective contraception throughout the study period.&#xD;
&#xD;
        Exclusion criteria;&#xD;
&#xD;
          1. Has been treated with biologic products (except for immunoglobulin preparation)&#xD;
&#xD;
          2. Have received immunoglobulin or blood preparation within 6 months before the study&#xD;
             drug administration&#xD;
&#xD;
          3. Received inoculation within 4 weeks before the study drug administration&#xD;
&#xD;
          4. Has a history of autoimmune disease or immunodeficiency&#xD;
&#xD;
          5. Has a clinically significant angioedema, hematemesis, anal hemorrhage, or hemoptysis&#xD;
&#xD;
          6. Has a history of acute myocardial infarction, cerebral infarction, cerebral&#xD;
             hemorrhage, or arteriosclerosis obliterate&#xD;
&#xD;
          7. With gross hematuria, occult bleeding in urine (&gt;=1+) and urine protein (&gt;=1+) , or&#xD;
             either of (&gt;=2+) at screening&#xD;
&#xD;
          8. Has a clinically significant vasculitis (e.g., multiple mononeuropathy)&#xD;
&#xD;
          9. Known to be positive for human immunodeficiency virus (HIV antigen and antibody),&#xD;
             hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody&#xD;
             (HBs antibody), hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibody, or&#xD;
             syphilis serology test&#xD;
&#xD;
         10. Known to be positive for human T-cell lymphotropic virus type 1 (HTVL-1) antibody at&#xD;
             screening&#xD;
&#xD;
         11. Known to be positive for QuantiFERON-TB Gold Test&#xD;
&#xD;
         12. Treated with ethical drug(s) within 4 weeks before the study drug administration&#xD;
             (except for disinfectants, eye drops)&#xD;
&#xD;
         13. Treated with non-prescription drug(s) within 2 weeks before the study drug&#xD;
             administration (except for disinfectants, eye drops)&#xD;
&#xD;
         14. Has participated in another clinical trial and received an investigational drug or&#xD;
             device within 6 months before the study drug administration&#xD;
&#xD;
         15. Received blood transfusion within 1 year, 400 mL or more whole blood donation within&#xD;
             12 weeks, or 200 mL or more whole blood donation within 4 weeks, or blood constituent&#xD;
             donation within 2 weeks before the study drug administration.&#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>
  <overall_official>
    <last_name>Kiyoshi Oketani</last_name>
    <role>Study Director</role>
    <affiliation>KAN Clinical Development Section, JAPAN/ASIA Clinical Research Product Creation Unit, Eisai Product Creation System</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Sagamihara</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>February 13, 2014</last_update_submitted>
  <last_update_submitted_qc>February 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy volunteers</keyword>
  <keyword>immunogenicity</keyword>
  <keyword>anti-E6011 antibody</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Quetmolimab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01731275
org study id: E6011-J081-001
nct id: NCT01731275
lead sponsor: 
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single
      ascending dose (SAD) administration of E6011 in Japanese healthy volunteers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants with Adverse Events
time frame: Up to Week 24
description: An Adverse Event (AE) is any untoward medical occurrence in a participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. The investigator or sub-investigator reviews all laboratory findings and determines if they constitute an AE. In-patient observation assessments will be performed during 1 week post-dose, followed by the out-patient observation assessments in groups: 0.0006, 0.006, 0.04, 0.2 mg/kg up to the end of Week 8 and in groups: 1, 3, 6, 10 kg/mg) up to the end of Week 24.
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Up to 24 Weeks post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: Up to 24 Weeks post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
time frame: Up to 24 Weeks post-dose
description: AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)]
time frame: Up to 24 Weeks post-dose
description: AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
measure: Plasma Decay Half-Life (t1/2)
time frame: Up to 24 Weeks post-dose
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
measure: Pharmacokinetic Parameter: Volume of Distribution (Vd)
time frame: Up to 24 Weeks post-dose
measure: Pharmacokinetic Parameter: Clearance (CL)
time frame: Up to 24 Weeks post-dose
arm group label: E6011
arm group type: Experimental
arm group label: E6011 Matching Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: E6011
description: A single ascending dose (SAD) administration of E6011 is administered to 8 groups as a 30-minute intravenous infusion at a dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.
arm group label: E6011
intervention type: Drug
intervention name: E6011 Matching Placebo
description: A SAD administration of E6011 Matching Placebo is administered to 2 participants in each of 8 groups as a 30-minute intravenous infusion at a placebo dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending E6011 Matching Placebo dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.
arm group label: E6011 Matching Placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kiyoshi Oketani
role: Study Director
affiliation: KAN Clinical Development Section, JAPAN/ASIA Clinical Research Product Creation Unit, Eisai Product Creation System
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Quetmolimab
mesh term: Antibodies, Monoclonal