A Study to Compare Two Formulations of Mirikizumab (LY3074828) in Healthy Participants

Summary

The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated. Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.

Timeline

Start

2021-10-05

Primary completion

2022-06-22

Completion

2022-06-22

Outcome

Mixed primary results

paper bioequivalence achieved for AUC0-tlast and AUC0-∞ PMID 40900263 ↗

paper the upper bound of the 90% CI of the geometric least squares mean ratio for Cmax was slightly above the bioequivalence upper threshold PMID 40900263 ↗

Publications

• Zhang X, Otani Y, Payne CD, Morris NJ, Chua L, Escobar R, Wang S, Shi G. Pharmacokinetic Bridging Between an Autoinjector and a Prefilled Syringe Following Subcutaneous Administration of Mirikizumab in Healthy Participants. Adv Ther. 2025 Nov;42(11):5529-5546. doi: 10.1007/s12325-025-03335-z. Epub 2025 Sep 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirikizumab	Monoclonal antibody	3 ml	Subcutaneous

Indications

No indication recorded.