A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants

Phase 1 Completed 60 enrolled Eli Lilly and Company

RandomizedParallel-groupDouble-blindBasic science

Summary

The purpose of this study is to compare two different formulations of mirikizumab in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Participants will remain in the study for about 12 weeks, after receiving study drug.

Timeline

Start: 2020-09-11
Primary completion: 2021-01-11
Completion: 2021-01-11

Publications

Otani Y, Feagan BG, D'Haens GR, Escobar R, Morris NJ, Payne CD, Ugolini Lopes M, Zhang X. Pharmacokinetic Comparability and Safety Between Original and Citrate-Free Mirikizumab Formulations for Subcutaneous Injections: Results from Three Clinical Trials. Adv Ther. 2025 May;42(5):2369-2384. doi: 10.1007/s12325-025-03158-y. Epub 2025 Mar 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirikizumab	Monoclonal antibody	200 mg	Subcutaneous

Indications

No indication recorded.