<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/NCT02237729</url>
  </required_header>
  <id_info>
    <org_study_id>B5381007</org_study_id>
    <secondary_id>REFLECTIONS B538-07</secondary_id>
    <nct_id>NCT02237729</nct_id>
  </id_info>
  <brief_title>A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))</brief_title>
  <acronym>B538-07</acronym>
  <official_title>Phase 1, Double Blind, Randomized, Parallel-group, 3-arm, Single-dose, Comparative Pharmacokinetic Study Of Pf-06410293 and Adalimumab Sourced From Us And Eu Administered To Healthy Male And Female Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm,&#xD;
      single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and&#xD;
      EU administered subcutaneously (SC) to healthy male and female volunteers&#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">March 2015</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>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>maximal serum concentration (Cmax)</measure>
    <time_frame>Day 1 - Day 50</time_frame>
    <description>maximal serum concentration (Cmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk)</measure>
    <time_frame>0-336 hours</time_frame>
    <description>area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)]</measure>
    <time_frame>Day 1 - Day 50</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>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC extrapolated to infinity (AUC0inf)</measure>
    <time_frame>Day 1 - Day 50</time_frame>
    <description>AUC extrapolated to infinity (AUC0inf)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters</measure>
    <time_frame>Day 1- Day 71</time_frame>
    <description>Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)</measure>
    <time_frame>Day 1- Day 71</time_frame>
    <description>Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US</measure>
    <time_frame>Day 1 - Day 50</time_frame>
    <description>maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US</measure>
    <time_frame>0-336 hours</time_frame>
    <description>area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk) for adalimumab EU as compared to adalimumab US</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US</measure>
    <time_frame>Day 1 - Day 50</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) for adalimumab EU as compared to adalimumab US</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US</measure>
    <time_frame>Day 1 - Day 50</time_frame>
    <description>AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to reach the maximum concentration (Tmax)</measure>
    <time_frame>Day 1 - Day 50</time_frame>
    <description>time to reach the maximum concentration (Tmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance (CL/F)</measure>
    <time_frame>Day 1 - Day 50</time_frame>
    <description>Apparent clearance (CL/F)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution (Vz/F)</measure>
    <time_frame>Day 1 - Day 50</time_frame>
    <description>Apparent volume of distribution (Vz/F)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (T1/2)</measure>
    <time_frame>Day 1 - Day 50</time_frame>
    <description>Terminal half-life (T1/2)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">362</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>PF-06410293</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Adalimumab-US</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Adalimumab-EU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PF-06410293</intervention_name>
    <description>PF-06410293 will be administered as a single 40 mg, subcutaneous dose</description>
    <arm_group_label>PF-06410293</arm_group_label>
    <other_name>Adalimumab-Pfizer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adalimumab-US</intervention_name>
    <description>Adalimumab-US will be administered as a single 40 mg, subcutaneous dose</description>
    <arm_group_label>Adalimumab-US</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adalimumab-EU</intervention_name>
    <description>Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose</description>
    <arm_group_label>Adalimumab-EU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female subjects between the ages of 18 and 45 years, inclusive.&#xD;
             Healthy is defined as no clinically relevant abnormalities identified by a detailed&#xD;
             medical history, complete physical examination including blood pressure and heart rate&#xD;
             measurement, 12 lead ECG and clinical laboratory tests.&#xD;
&#xD;
          -  Body Mass Index (BMI) of 19.0 to 30.5 kg/m2; and a total body weight &gt;60 kg (132 lbs).&#xD;
&#xD;
          -  Chest X ray with no evidence of current, active TB or previous (inactive) TB, general&#xD;
             infections, heart failure, malignancy, or other clinically significant abnormalities&#xD;
             taken at Screening or within 24 weeks prior to Day 1 and read by a qualified&#xD;
             radiologist.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,&#xD;
             autoimmune, or allergic disease (including drug allergies, but excluding untreated,&#xD;
             asymptomatic, seasonal allergies at the time of dosing).&#xD;
&#xD;
          -  Previous history of cancer, except for adequately treated basal cell or squamous cell&#xD;
             carcinoma of the skin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>De La Pedraja Radiology Associates</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SeaView Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SeaView Research, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SeaView Reseach Screening Office</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SeaView Research, Inc. (Screening Office)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vince &amp; Associates Clinical Research, Inc.</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vince &amp; Associates Clinical Research, Inc.</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prism Research, LLC</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5381007&amp;StudyName=A%20Study%20Of%20PF-06410293%20%28Adalimumab-Pfizer%29%20And%20Adalimumab%20%28Humira%29%20In%20Healthy%20Subjects%20%28REFLECTIONS%20B538-07%29%29</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>April 10, 2015</last_update_submitted>
  <last_update_submitted_qc>April 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>healthy subjects</keyword>
  <keyword>immunology</keyword>
  <keyword>PK</keyword>
  <keyword>Phase 1</keyword>
  <keyword>bioequivalence</keyword>
  <keyword>biosimilarity</keyword>
  <keyword>adalimumab</keyword>
  <keyword>single dose.</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adalimumab</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/NCT02237729
org study id: B5381007
secondary id: REFLECTIONS B538-07
nct id: NCT02237729
lead sponsor: 
has dmc: No
This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm,
      single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and
      EU administered subcutaneously (SC) to healthy male and female volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: maximal serum concentration (Cmax)
time frame: Day 1 - Day 50
description: maximal serum concentration (Cmax)
measure: area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk)
time frame: 0-336 hours
description: area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk)
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)]
time frame: Day 1 - Day 50
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: AUC extrapolated to infinity (AUC0inf)
time frame: Day 1 - Day 50
description: AUC extrapolated to infinity (AUC0inf)
measure: Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters
time frame: Day 1- Day 71
description: Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters
measure: Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)
time frame: Day 1- Day 71
description: Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)
measure: maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US
time frame: Day 1 - Day 50
description: maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US
measure: area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US
time frame: 0-336 hours
description: area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk) for adalimumab EU as compared to adalimumab US
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US
time frame: Day 1 - Day 50
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) for adalimumab EU as compared to adalimumab US
measure: AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US
time frame: Day 1 - Day 50
description: AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US
measure: time to reach the maximum concentration (Tmax)
time frame: Day 1 - Day 50
description: time to reach the maximum concentration (Tmax)
measure: Apparent clearance (CL/F)
time frame: Day 1 - Day 50
description: Apparent clearance (CL/F)
measure: Apparent volume of distribution (Vz/F)
time frame: Day 1 - Day 50
description: Apparent volume of distribution (Vz/F)
measure: Terminal half-life (T1/2)
time frame: Day 1 - Day 50
description: Terminal half-life (T1/2)
arm group label: PF-06410293
arm group type: Experimental
arm group label: Adalimumab-US
arm group type: Active Comparator
arm group label: Adalimumab-EU
arm group type: Active Comparator
description: Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
intervention type: Biological
intervention name: PF-06410293
description: PF-06410293 will be administered as a single 40 mg, subcutaneous dose
arm group label: PF-06410293
other name: Adalimumab-Pfizer
intervention type: Biological
intervention name: Adalimumab-US
description: Adalimumab-US will be administered as a single 40 mg, subcutaneous dose
arm group label: Adalimumab-US
intervention type: Biological
intervention name: Adalimumab-EU
description: Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
arm group label: Adalimumab-EU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5381007&StudyName=A%20Study%20Of%20PF-06410293%20%28Adalimumab-Pfizer%29%20And%20Adalimumab%20%28Humira%29%20In%20Healthy%20Subjects%20%28REFLECTIONS%20B538-07%29%29
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Adalimumab