drugset
drugset / Trial / NCT04940364

A Study to Examine the Safety, Tolerability and Biological Effects of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Adult Japanese Healthy Volunteers

NCT04940364 ↗

Phase 1 Completed 30 enrolled Regeneron Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of the study is to assess the concentration-time profiles of total pozelimab, total C5, cemdisiran, and cemdisiran metabolite(s) in Japanese adult participants following single doses of intravenous (IV) and 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 evaluate the safety and tolerability of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants * To assess the pharmacodynamic (PD) profile of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants * To assess the immunogenicity of pozelimab and cemdisiran in healthy Japanese adult participants

Timeline

Start
2021-08-04
Primary completion
2022-06-22
Completion
2022-06-22

Drugs

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

Indications

No indication recorded.