Overview

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pozelimab in Combination With Cemdisiran in Healthy Adult Volunteers

Status:
Active, not recruiting

Trial end date:
2021-07-23

Target enrollment:

Participant gender:

Summary

The primary objective of the study is to evaluate the safety and tolerability of ascending doses of subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart. The secondary objectives of the study are: - To assess the concentration-time profiles of total pozelimab, total complement component 5 (C5), cemdisiran, and cemdisiran metabolite(s) following single ascending doses of SC pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart - To assess the pharmacodynamic (PD) profile of ascending doses of SC pozelimab and SC cemdisiran, as well as when administered on the same day or sequentially 28 days apart - To assess the immunogenicity of pozelimab and cemdisiran

Phase:

Phase 1

Details

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator:

Alnylam Pharmaceuticals