<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/NCT04491838</url>
  </required_header>
  <id_info>
    <org_study_id>R3918-HV-2014</org_study_id>
    <secondary_id>2020-002365-33</secondary_id>
    <nct_id>NCT04491838</nct_id>
  </id_info>
  <brief_title>Study of a Single Subcutaneous Dose of Pozelimab Produced From Two Different Manufacturing Processes in Healthy Adult Participants</brief_title>
  <official_title>A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Pozelimab Produced From Two Different Manufacturing Processes in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Regeneron Pharmaceuticals</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to compare the pharmacokinetic(PK) profile of pozelimab&#xD;
      produced by the original manufacturing process (Process A) compared to a second manufacturing&#xD;
      process (Process B)&#xD;
&#xD;
      The secondary objectives of the study are:&#xD;
&#xD;
        -  Assess the safety and tolerability of a single SC dose of pozelimab produced by the 2&#xD;
           manufacturing processes&#xD;
&#xD;
        -  Assess the immunogenicity of pozelimab produced by the 2 manufacturing processes&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Actual">March 5, 2021</completion_date>
  <primary_completion_date type="Actual">March 5, 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>Assess the time of the last positive concentration (AUClast) pharmacokinetic (PK) profile of pozelimab in Process A</measure>
    <time_frame>Up to 16 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the time of the last positive concentration (AUClast) PK profile of pozelimab in Process B</measure>
    <time_frame>Up to 16 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess peak concentration (Cmax) PK profile of pozelimabin in Process A</measure>
    <time_frame>Up to 16 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess peak concentration (Cmax) PK profile of pozelimab in Process B</measure>
    <time_frame>Up to 16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment emergent adverse events (TEAEs)</measure>
    <time_frame>Up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of anti-drug antibodies (ADA) to pozelimab over time</measure>
    <time_frame>Up to 16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Process A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized 1:1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Process B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized 1:1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pozelimab</intervention_name>
    <description>Single subcutaneous (SC) injection</description>
    <arm_group_label>Process A</arm_group_label>
    <arm_group_label>Process B</arm_group_label>
    <other_name>REGN3918</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Has a body weight of 55 kg to 100 kg and a body mass index between 18 kg/m2 and 30&#xD;
             kg/m2 inclusive at the screening visit&#xD;
&#xD;
          -  Judged to be in good health based on medical history, physical examination, vital&#xD;
             signs measurements, and ECG performed at screening and/or prior to administration of&#xD;
             initial dose of study drug&#xD;
&#xD;
          -  Is in good health based on laboratory safety testing obtained at the screening visit.&#xD;
             NOTE: Subject with a history of Gilbert's disease can be enrolled in the study&#xD;
&#xD;
          -  Willing to undergo vaccination against N meningitidis unless subjects have&#xD;
             documentation of completed series of vaccinations within the past 2 years of the&#xD;
             screening visit&#xD;
&#xD;
          -  Must have two negative COVID-19 tests within 7 days prior to study drug administration&#xD;
             as defined in the protocol&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  History of clinically significant cardiovascular, respiratory, hepatic, renal,&#xD;
             gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as&#xD;
             assessed by the investigator&#xD;
&#xD;
          -  Hospitalization (&gt;24 h) for any reason within 90 days of the screening visit&#xD;
&#xD;
          -  Has a confirmed positive drug test result at the screening visit and/or prior to&#xD;
             enrollment; and/or a history of recreational drug use (eg, marijuana) and/or drug or&#xD;
             alcohol abuse within a year prior to the screening visit&#xD;
&#xD;
          -  Is positive for HIV, hepatitis B, or hepatitis C antibody as defined in the protocol&#xD;
&#xD;
          -  Known or suspected COVID-19 disease&#xD;
&#xD;
          -  History of tuberculosis, systemic fungal diseases, or meningococcal infection&#xD;
&#xD;
          -  Known allergy or intolerance to penicillin class antibiotics or macrolides; any&#xD;
             contraindication to azrithromycin per local prescribing information&#xD;
&#xD;
        Note: Other protocol-defined Inclusion/ Exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Antwerpen</city>
        <zip>B-2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>
  <!-- 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/NCT04491838
org study id: R3918-HV-2014
secondary id: 2020-002365-33
nct id: NCT04491838
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of the study is to compare the pharmacokinetic(PK) profile of pozelimab
      produced by the original manufacturing process (Process A) compared to a second manufacturing
      process (Process B)

      The secondary objectives of the study are:

        -  Assess the safety and tolerability of a single SC dose of pozelimab produced by the 2
           manufacturing processes

        -  Assess the immunogenicity of pozelimab produced by the 2 manufacturing processes
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assess the time of the last positive concentration (AUClast) pharmacokinetic (PK) profile of pozelimab in Process A
time frame: Up to 16 weeks
measure: Assess the time of the last positive concentration (AUClast) PK profile of pozelimab in Process B
time frame: Up to 16 weeks
measure: Assess peak concentration (Cmax) PK profile of pozelimabin in Process A
time frame: Up to 16 weeks
measure: Assess peak concentration (Cmax) PK profile of pozelimab in Process B
time frame: Up to 16 weeks
measure: Incidence of treatment emergent adverse events (TEAEs)
time frame: Up to 16 weeks
measure: Incidence of anti-drug antibodies (ADA) to pozelimab over time
time frame: Up to 16 weeks
arm group label: Process A
arm group type: Experimental
description: Randomized 1:1
arm group label: Process B
arm group type: Experimental
description: Randomized 1:1
intervention type: Drug
intervention name: Pozelimab
description: Single subcutaneous (SC) injection
arm group label: Process A
arm group label: Process B
other name: REGN3918
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
facility: 
country: Belgium
responsible party type: Sponsor
sharing ipd: Yes
ipd description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
ipd access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
ipd url: https://vivli.org/