NCT05069896

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

A Bioequivalence Study of Injections of Mirikizumab Solution Using Investigational 1-mL and 2-mL Pre-Filled Syringes and Investigational 1-mL and 2-mL Autoinjectors in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 237 (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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Mirikizumab Prefilled Syringe	Administered SC by prefilled syringe
DRUG	Mirikizumab Autoinjector	Administered SC by autoinjector

Timeline

• Start date: 2021-10-05
• Primary completion: 2022-06-22
• Completion: 2022-06-22
• First posted: 2021-10-06
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study