xml: <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/NCT05976360</url>
    </required_header>
    <id_info>
      <org_study_id>PKM14161</org_study_id>
      <secondary_id>U1111-1290-9436</secondary_id>
      <nct_id>NCT05976360</nct_id>
    </id_info>
    <brief_title>A Study to Investigate the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants</brief_title>
    <official_title>A Randomized, Open-label, Parallel Design Study of the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products After Administration of Single Subcutaneous Doses</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sanofi</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Regeneron Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Sanofi</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetics of&#xD;
        2 different dupilumab drug product in healthy volunteers. The duration per participant is up&#xD;
        to 11 weeks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Duration per participant is up to 11 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 2, 2014</start_date>
    <completion_date type="Actual">January 17, 2015</completion_date>
    <primary_completion_date type="Actual">January 17, 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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum serum concentration observed: Cmax</measure>
      <time_frame>Up to Day 57</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to reach Cmax (tmax)</measure>
      <time_frame>Up to Day 57</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast)</measure>
      <time_frame>Up to Day 57</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of treatment-emergent adverse events (TEAEs)</measure>
      <time_frame>Up to Day 57</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of anti-dupilumab antibodies (ADA)</measure>
      <time_frame>Up to Day 57</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">38</enrollment>
    <condition>Healthy Volunteer</condition>
    <arm_group>
      <arm_group_label>Dupilumab drug product 1</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>A single subcutaneous injection on Day 1</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dupilumab drug product 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A single subcutaneous injection on Day 1</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dupilumab (SAR231893)</intervention_name>
      <description>Injection solution, subcutaneous</description>
      <arm_group_label>Dupilumab drug product 1</arm_group_label>
      <other_name>REGN668</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dupilumab (SAR231893)</intervention_name>
      <description>Injection solution, subcutaneous.</description>
      <arm_group_label>Dupilumab drug product 2</arm_group_label>
      <other_name>REGN668</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female participants, between 18 and 65 years of age, inclusive.&#xD;
  &#xD;
            -  Certified as healthy by a comprehensive clinical assessment (detailed medical history&#xD;
               and complete physical examination).&#xD;
  &#xD;
            -  Body weight between 70.0 and 90.0 kg, inclusive.&#xD;
  &#xD;
            -  Having given written informed consent prior to undertaking any study-related&#xD;
               procedure.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any history or presence of clinically relevant cardiovascular, pulmonary,&#xD;
               gastrointestinal, hepatic, renal, metabolic, hematological, neurological,&#xD;
               osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or&#xD;
               infectious disease, or signs of acute illness.&#xD;
  &#xD;
            -  Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice&#xD;
               a month).&#xD;
  &#xD;
            -  Blood donation or collection totaling more than 250 mL (including collections during&#xD;
               study screening) within 2 months before inclusion on Day -1.&#xD;
  &#xD;
            -  Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or&#xD;
               asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20&#xD;
               mmHg within 3 minutes when changing from supine to standing position.&#xD;
  &#xD;
            -  History of light-headedness or syncope during blood collection or injection of&#xD;
               medications.&#xD;
  &#xD;
            -  Presence or history of drug hypersensitivity, or allergic disease diagnosed and&#xD;
               treated by a physician.&#xD;
  &#xD;
            -  History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per&#xD;
               day on a regular basis).&#xD;
  &#xD;
            -  If female, pregnancy (defined as positive β-human chorionic gonadotropin blood test)&#xD;
               or breast-feeding.&#xD;
  &#xD;
            -  Any history or presence of clinically relevant cardiovascular, pulmonary,&#xD;
               gastrointestinal, hepatic, renal, metabolic, hematological, neurological,&#xD;
               osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or&#xD;
               infectious disease, or signs of acute illness.&#xD;
  &#xD;
            -  Participation in any clinical research study evaluating another investigational drug&#xD;
               or therapy within 30 days or 5 elimination half-lives of the respective&#xD;
               investigational drug, whichever is longer, of the inclusion visit.&#xD;
  &#xD;
            -  Any participant who, in the judgment of the Investigator, is likely to be noncompliant&#xD;
               during the study, or unable to cooperate because of a language problem or poor mental&#xD;
               development.&#xD;
  &#xD;
          The above information is not intended to contain all considerations relevant to a patient's&#xD;
          potential participation in a clinical trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Prism Research-Site Number:840002</name>
        <address>
          <city>Saint Paul</city>
          <state>Minnesota</state>
          <zip>55144</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Biokinetic Clinical Applications-Site Number:840003</name>
        <address>
          <city>Springfield</city>
          <state>Missouri</state>
          <zip>65802</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 24, 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antibodies, Monoclonal</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976360
  org study id: PKM14161
  secondary id: U1111-1290-9436
  nct id: NCT05976360
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetics of
        2 different dupilumab drug product in healthy volunteers. The duration per participant is up
        to 11 weeks.
  Duration per participant is up to 11 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Maximum serum concentration observed: Cmax
  time frame: Up to Day 57
  measure: Time to reach Cmax (tmax)
  time frame: Up to Day 57
  measure: Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast)
  time frame: Up to Day 57
  measure: Incidence of treatment-emergent adverse events (TEAEs)
  time frame: Up to Day 57
  measure: Incidence of anti-dupilumab antibodies (ADA)
  time frame: Up to Day 57
  arm group label: Dupilumab drug product 1
  arm group type: Active Comparator
  description: A single subcutaneous injection on Day 1
  arm group label: Dupilumab drug product 2
  arm group type: Experimental
  description: A single subcutaneous injection on Day 1
  intervention type: Drug
  intervention name: Dupilumab (SAR231893)
  description: Injection solution, subcutaneous
  arm group label: Dupilumab drug product 1
  other name: REGN668
  intervention type: Drug
  intervention name: Dupilumab (SAR231893)
  description: Injection solution, subcutaneous.
  arm group label: Dupilumab drug product 2
  other name: REGN668
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Antibodies, Monoclonal
  sharing ipd: No