drugset
drugset / Trial / NCT04601844

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

NCT04601844 ↗

Phase 1 Completed 19 enrolled Regeneron Pharmaceuticals Alnylam Pharmaceuticals · collab
Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2020-11-16
Primary completion
2021-07-23
Completion
2021-07-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Cemdisiran Small interfering RNA (siRNA) — Subcutaneous
Subject Pozelimab Monoclonal antibody — Subcutaneous

Indications

No indication recorded.