NCT04548219

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

Relative Bioavailability of a Mirikizumab Test Formulation Compared to the Reference Formulation in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Mirikizumab	Reference and test formulations of mirikizumab administered as a SC injection.

Timeline

• Start date: 2020-09-11
• Primary completion: 2021-01-11
• Completion: 2021-01-11
• First posted: 2020-09-14
• Last updated: 2024-01-25
• Results posted: 2024-01-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study