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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Pozelimab

• Registration Number: NCT04491838
• Lead Sponsor: Regeneron Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-27
• Study First Posted: 2020-07-29
• Study Start: 2020-08-03
• Status Verified: 2021-03
• Primary Completion: 2021-03-05
• Study Completion: 2021-03-05
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Process A	Pozelimab	Randomized 1:1
Process B	Pozelimab	Randomized 1:1

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Regeneron Study Site; 🇧🇪 Antwerpen, Belgium