<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/NCT02213315</url>
  </required_header>
  <id_info>
    <org_study_id>D2190C00016</org_study_id>
    <nct_id>NCT02213315</nct_id>
  </id_info>
  <brief_title>A Double-blind, Placebo-controlled, Single-dose Study to Evaluate the PK, IM, and Safety in Japanese Subjects</brief_title>
  <official_title>A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Pharmacokinetics, Immunogenicity, and Safety of Mavrilimumab in Healthy Japanese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedImmune LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedImmune LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A phase 1 randomized, double blind single-dose study to evaluate the PK and immunogenicity of&#xD;
      single SC 100 and 150 mg doses of mavrilimumab in healthy adult Japanese subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group, single-dose&#xD;
      study to evaluate the PK, immunogenicity, and safety of mavrilimumab at doses of 100 and 150&#xD;
      mg in healthy adult Japanese subjects. The study will be conducted at one site in Europe and&#xD;
      subjects will be randomized in a 5:5:2 ratio to 100, 150mg mavrilimumab and placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PK profile of mavrilimumab</measure>
    <time_frame>from dosing to day 85</time_frame>
    <description>•Non-compartmental PK parameters following a single-dose of mavrilimumab to analyse •Maximum observed concentration (Cmax); area under the concentration-time curve (AUC); time to maximum concentration (Tmax) and half-life (t1/2) from dosing to Day 85 •The number and percentage of subjects that are ADA positive will be summarized by dose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the safety of mavrilimumab</measure>
    <time_frame>from dosing to day 85</time_frame>
    <description>•The secondary outcome of the study is the safety of mavrilimumab as measured by the frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) from dosing to day 85</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>100mg arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100mg dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>150mg arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>150mg dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>100mg Mavrilimumab</intervention_name>
    <description>100mg Mavrilimumab</description>
    <arm_group_label>100mg arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>150mg mavrilimumab</intervention_name>
    <description>150mg mavrilmumab</description>
    <arm_group_label>150mg arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is of Japanese ethnicity&#xD;
&#xD;
          -  No evidence of clinically significant respiratory disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition that, would interfere with the evaluation of the study drug or safety of&#xD;
             subjects.&#xD;
&#xD;
          -  Subject has a known hypersensitivity to any components of the investigational product.&#xD;
&#xD;
          -  History of infection requiring hospitalization or treatment with IV antibiotics within&#xD;
             12 weeks before screening, or evidence of clinically significant active infection.&#xD;
&#xD;
          -  Subject has a history or present condition of malignancy.&#xD;
&#xD;
          -  Subject has a history or presence of drug addiction (urine test) or has alcohol&#xD;
             consumption (breath test) of more than 21 (males) or 14 (females) units of alcohol per&#xD;
             week.&#xD;
&#xD;
          -  Any blood donation or significant loss of blood within 56 days of study initiation,&#xD;
&#xD;
          -  Receipt of live (attenuated) vaccine within the 4 weeks before screening or during the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>malcolm Boyce, BSc MB ChB FRCP FFPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hammersmith Medicines Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>January 8, 2015</last_update_submitted>
  <last_update_submitted_qc>January 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Volunteers, Rheumatoid Arthritis, mavrilimumab</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mavrilimumab</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/NCT02213315
org study id: D2190C00016
nct id: NCT02213315
lead sponsor: 
has dmc: No
A phase 1 randomized, double blind single-dose study to evaluate the PK and immunogenicity of
      single SC 100 and 150 mg doses of mavrilimumab in healthy adult Japanese subjects.
This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group, single-dose
      study to evaluate the PK, immunogenicity, and safety of mavrilimumab at doses of 100 and 150
      mg in healthy adult Japanese subjects. The study will be conducted at one site in Europe and
      subjects will be randomized in a 5:5:2 ratio to 100, 150mg mavrilimumab and placebo.
allocation: Randomized
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: PK profile of mavrilimumab
time frame: from dosing to day 85
description: •Non-compartmental PK parameters following a single-dose of mavrilimumab to analyse •Maximum observed concentration (Cmax); area under the concentration-time curve (AUC); time to maximum concentration (Tmax) and half-life (t1/2) from dosing to Day 85 •The number and percentage of subjects that are ADA positive will be summarized by dose
measure: To evaluate the safety of mavrilimumab
time frame: from dosing to day 85
description: •The secondary outcome of the study is the safety of mavrilimumab as measured by the frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) from dosing to day 85
arm group label: 100mg arm
arm group type: Experimental
description: 100mg dose
arm group label: 150mg arm
arm group type: Experimental
description: 150mg dose
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: 100mg Mavrilimumab
description: 100mg Mavrilimumab
arm group label: 100mg arm
intervention type: Drug
intervention name: 150mg mavrilimumab
description: 150mg mavrilmumab
arm group label: 150mg arm
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: malcolm Boyce, BSc MB ChB FRCP FFPM
role: Principal Investigator
affiliation: Hammersmith Medicines Research
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Mavrilimumab
mesh term: Antibodies, Monoclonal