An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution in Healthy Participants
Eli Lilly and Company
Summary
The main purpose of this study is to assess the safety and tolerability of mirikizumab (LY3074828) solution formulation administered as a single injection compared with two injections under the skin in healthy participants. Blood tests will be performed to investigate how the body processes the study drug. For each participant, the study will last about 15 weeks.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Are overtly healthy males or females as determined by medical evaluation including: * medical history * physical examination * clinical laboratory tests * ECG, and * vital signs. * Have clinical laboratory test results at screening and Day -1 within normal reference range. * Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per square meter (kg/m²), inclusive. Exclusion Criteria: * Have significant allergies to humanized monoclonal antibodies or known allergies to mirikizumab, related compounds or any components of the formulation, or h…