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

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04491838
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Pozelimab — DRUG
    Single subcutaneous (SC) injection

Study Details

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

Key Dates

Start date
Aug 3, 2020
Status verified
Mar 2021
Primary completion
Mar 5, 2021
Completion
Mar 5, 2021

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Process A
    Randomized 1:1
  • Experimental: Process B
    Randomized 1:1

Primary Outcome Measure

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

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