drugset
drugset / Trial / NCT04491838

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

NCT04491838 ↗

Phase 1 Completed 40 enrolled Regeneron Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2020-08-03
Primary completion
2021-03-05
Completion
2021-03-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Pozelimab Monoclonal antibody — Subcutaneous

Indications

No indication recorded.