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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2023
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).
Epistemonikos ID: c051de2c2f99461d9bf6ed1fd5755301b256ad74
First added on: Feb 19, 2024