NCT04491838

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Pozelimab	Single subcutaneous (SC) injection

Timeline

• Start date: 2020-08-03
• Primary completion: 2021-03-05
• Completion: 2021-03-05
• First posted: 2020-07-29
• Last updated: 2021-03-23

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study