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/NCT05976386</url>
    </required_header>
    <id_info>
      <org_study_id>PKM17324</org_study_id>
      <secondary_id>U1111-1266-7002</secondary_id>
      <nct_id>NCT05976386</nct_id>
    </id_info>
    <brief_title>Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults</brief_title>
    <official_title>A Randomized, Open-label, Parallel Design, Single Dose Study to Compare the Pharmacokinetics of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults</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>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a parallel group, treatment, Phase 1, open-label, 2-arm study to demonstrate&#xD;
        pharmacokinetic comparability between subcutaneous (SC) single dose of new dupilumab product&#xD;
        and SC single dose of current dupilumab product in male and female healthy participants aged&#xD;
        18 to 65 years.&#xD;
  &#xD;
        The estimated duration is up to 21 days of screening period, followed by the treatment day&#xD;
        with a follow-up treatment period of 42 days until the end of study (EOS) visit. Total&#xD;
        duration from screening to EOS will be 64 days maximum.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Duration per participant is up to 64 days&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 8, 2021</start_date>
    <completion_date type="Actual">September 24, 2021</completion_date>
    <primary_completion_date type="Actual">September 24, 2021</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 of functional dupilumab (Cmax)</measure>
      <time_frame>Pre-dose on Day 1 up to Day 43</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>Pre-dose on Day 1 up to Day 43</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of treatment-emergent adverse events (TEAEs)</measure>
      <time_frame>Day 1 up to Day 43</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">182</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>New dupilumab product</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A single subcutaneous injection on Day 1</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Current dupilumab product</arm_group_label>
      <arm_group_type>Active Comparator</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>Current dupilumab product</arm_group_label>
      <arm_group_label>New dupilumab product</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;
            -  Body weight between 65.0 and 95.0 kg, inclusive.&#xD;
  &#xD;
            -  Certified as healthy by a comprehensive clinical assessment (detailed medical history&#xD;
               and complete physical examination).&#xD;
  &#xD;
            -  Having given written informed consent prior to undertaking any study-related&#xD;
               procedure.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic,&#xD;
               renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric,&#xD;
               systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute&#xD;
               illness.&#xD;
  &#xD;
            -  Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting&#xD;
               only: more than twice a month).&#xD;
  &#xD;
            -  Blood donation, any volume, within 2 months before inclusion.&#xD;
  &#xD;
            -  Presence or history of drug or biologic hypersensitivity, or allergic disease&#xD;
               diagnosed and treated by a physician (excluding seasonal allergy).&#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;
            -  Smoking regularly and unable to stop smoking during the inpatient portion of the study&#xD;
               (occasional smoker can be enrolled).&#xD;
  &#xD;
            -  If female, pregnancy (defined as positive β-human chorionic gonadotropin (HCG) blood&#xD;
               test) or breastfeeding.&#xD;
  &#xD;
            -  Any biologics (antibody or its derivatives) given within 4 months before inclusion or&#xD;
               within 5 half-lives (whichever takes longer).&#xD;
  &#xD;
            -  Participation in any previous clinical trial of dupilumab.&#xD;
  &#xD;
            -  Participation in any clinical research study evaluating another investigational drug&#xD;
               or therapy in which the inclusion visit for the current study will be within 30 days&#xD;
               of receiving the drug or 5 elimination half-lives (whichever is longer).&#xD;
  &#xD;
            -  Participant not suitable for participation, whatever the reason, as judged by the&#xD;
               Investigator, including medical or clinical conditions, or participants potentially at&#xD;
               risk of noncompliance to study procedures.&#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>Clinical Pharmacology of Miami-Site Number:8400001</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33014</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 9, 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>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
    </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/NCT05976386
  org study id: PKM17324
  secondary id: U1111-1266-7002
  nct id: NCT05976386
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  This is a parallel group, treatment, Phase 1, open-label, 2-arm study to demonstrate
        pharmacokinetic comparability between subcutaneous (SC) single dose of new dupilumab product
        and SC single dose of current dupilumab product in male and female healthy participants aged
        18 to 65 years.
  
        The estimated duration is up to 21 days of screening period, followed by the treatment day
        with a follow-up treatment period of 42 days until the end of study (EOS) visit. Total
        duration from screening to EOS will be 64 days maximum.
  Duration per participant is up to 64 days
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Maximum serum concentration of functional dupilumab (Cmax)
  time frame: Pre-dose on Day 1 up to Day 43
  measure: Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast)
  time frame: Pre-dose on Day 1 up to Day 43
  measure: Incidence of treatment-emergent adverse events (TEAEs)
  time frame: Day 1 up to Day 43
  arm group label: New dupilumab product
  arm group type: Experimental
  description: A single subcutaneous injection on Day 1
  arm group label: Current dupilumab product
  arm group type: Active Comparator
  description: A single subcutaneous injection on Day 1
  intervention type: Drug
  intervention name: Dupilumab (SAR231893)
  description: Injection solution Subcutaneous
  arm group label: Current dupilumab product
  arm group label: New dupilumab product
  other name: REGN668
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org