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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Pozelimab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Process A<br>Randomized 1:1 | Drug: Pozelimab<br>* Single subcutaneous (SC) injection<br>* Other names: REGN3918;|
| Experimental: Process B<br>Randomized 1:1 | Drug: Pozelimab<br>* Single subcutaneous (SC) injection<br>* Other names: REGN3918;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the time of the last positive concentration (AUClast) pharmacokinetic (PK) profile of pozelimab in Process A |  | Up to 16 weeks | 
| Assess the time of the last positive concentration (AUClast) PK profile of pozelimab in Process B |  | Up to 16 weeks | 
| Assess peak concentration (Cmax) PK profile of pozelimabin in Process A |  | Up to 16 weeks | 
| Assess peak concentration (Cmax) PK profile of pozelimab in Process B |  | Up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events (TEAEs) |  | Up to 16 weeks | 
| Incidence of anti-drug antibodies (ADA) to pozelimab over time |  | Up to 16 weeks |