NCT05644353

A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants

A Bioequivalence Study of Subcutaneous Injections of Mirikizumab Reference Solution Using Investigational 1-mL and 2-mL Prefilled Syringes and Mirikizumab Test Solution Formulation Using Investigational 1-mL and 2-mL Prefilled Syringes in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via pre-filled syringe compared to mirikizumab (reference) solution given via pre-filled syringe. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated. Screening is required within 35 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Mirikizumab	Administered SC.

Timeline

• Start date: 2022-12-05
• Primary completion: 2023-05-25
• Completion: 2023-05-25
• First posted: 2022-12-09
• Last updated: 2025-03-28
• Results posted: 2025-03-28

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study