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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

Healthy Clinical Trial

Official title:
An Open-Label Parallel-Dose Study of the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Japanese Healthy Volunteers

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04940364
Study type Interventional
Source Regeneron Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date August 4, 2021
Completion date June 22, 2022
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