A Study of Mirikizumab (LY3074828) in Healthy Participants

• Status: Completed
• Trial end date: 2018-07-16
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to explore the safety and tolerability of mirikizumab in healthy Japanese and Caucasian participants. The study will also estimate how much mirikizumab gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 16 weeks for each participant.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Mirikizumab

Criteria

Inclusion Criteria:

• Are overtly healthy males or females, as determined by medical history and physical examination.

• Are first generation Japanese or are Caucasian.

• Have a body mass index (BMI) of 18.0 kilograms per square meter (kg/m2) to 32.0 kg/m2, inclusive, at screening.

• Have a body weight of 40.0 kg or higher for Cohorts 1, 2, 3 and 4, and 48.0 kg or higher for Cohort 5.

Exclusion Criteria:

• Have had symptomatic herpes zoster within 3 months of screening.

• Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-rays (posterior anterior and lateral), and TB testing.

• Have received live vaccine(s) within 1 month of screening or intend to during the study.

• Are immunocompromised.

• Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.