A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants

Summary

This is a 2-part, Phase 1 study, with 1 arm in Part 1 and a randomized parallel design in Part 2. The purpose of this study is to evaluate the comparability of pharmacokinetics, safety and tolerability of two different amlitelimab drug products (DPs) after administration of a single subcutaneus (SC) dose in healthy adult participants. Study details include: The study duration for a participant will be approximately 17 weeks. The study includes a screening period of up to 28 days, a 4-day institutionalization period, and a follow up period for approximately 89 days (9 visits).

Timeline

Start

2022-04-28

Primary completion

2023-05-22

Completion

2023-05-22

Drugs

Indications

No indication recorded.