A Study of Mirikizumab (LY3074828) in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 20 - 64 |
| Updated: | 8/25/2018 |
| Start Date: | November 4, 2015 |
| End Date: | July 16, 2018 |
A Single-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3074828 in Japanese and Caucasian Healthy Subjects
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.
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.
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.
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