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Study of a Single Subcutaneous Dose of Pozelimab Produced From Two Different Manufacturing Processes in Healthy Adult Participants

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04491838
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
7
Actual Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 3, 2020
Actual Primary Completion Date :
Mar 5, 2021
Actual Study Completion Date :
Mar 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Process A

Randomized 1:1

Drug: Pozelimab
Single subcutaneous (SC) injection
Other Names:
  • REGN3918

    		•
    Experimental: Process B

    Randomized 1:1

    Drug: Pozelimab
    Single subcutaneous (SC) injection
    Other Names:
  • REGN3918

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assess the time of the last positive concentration (AUClast) pharmacokinetic (PK) profile of pozelimab in Process A [Up to 16 weeks]

    2. Assess the time of the last positive concentration (AUClast) PK profile of pozelimab in Process B [Up to 16 weeks]

    3. Assess peak concentration (Cmax) PK profile of pozelimabin in Process A [Up to 16 weeks]

    4. Assess peak concentration (Cmax) PK profile of pozelimab in Process B [Up to 16 weeks]

    Secondary Outcome Measures

    1. Incidence of treatment emergent adverse events (TEAEs) [Up to 16 weeks]

    2. Incidence of anti-drug antibodies (ADA) to pozelimab over time [Up to 16 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:

    • Has a body weight of 55 kg to 100 kg and a body mass index between 18 kg/m2 and 30 kg/m2 inclusive at the screening visit

    • Judged to be in good health based on medical history, physical examination, vital signs measurements, and ECG performed at screening and/or prior to administration of initial dose of study drug

    • Is in good health based on laboratory safety testing obtained at the screening visit. NOTE: Subject with a history of Gilbert's disease can be enrolled in the study

    • Willing to undergo vaccination against N meningitidis unless subjects have documentation of completed series of vaccinations within the past 2 years of the screening visit

    • Must have two negative COVID-19 tests within 7 days prior to study drug administration as defined in the protocol

    Key Exclusion Criteria:

    • History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator

    • Hospitalization (>24 h) for any reason within 90 days of the screening visit

    • Has a confirmed positive drug test result at the screening visit and/or prior to enrollment; and/or a history of recreational drug use (eg, marijuana) and/or drug or alcohol abuse within a year prior to the screening visit

    • Is positive for HIV, hepatitis B, or hepatitis C antibody as defined in the protocol

    • Known or suspected COVID-19 disease

    • History of tuberculosis, systemic fungal diseases, or meningococcal infection

    • Known allergy or intolerance to penicillin class antibiotics or macrolides; any contraindication to azrithromycin per local prescribing information

    Note: Other protocol-defined Inclusion/ Exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regeneron Study Site Antwerpen Belgium B-2060

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04491838
    Other Study ID Numbers:
    • R3918-HV-2014
    • 2020-002365-33
    First Posted:
    Jul 29, 2020
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 23, 2021