Healthy
Conditions
Brief 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.
Interventions
DRUGMirikizumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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 history of significant atopy. * Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs. * Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions. * Are immunocompromised. * Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing. * Have received treatment with biologic agents within 3 months or 5 half-lives, whichever is longer, prior to dosing. * Have previously received mirikizumab. * Have an abnormality in the 12-lead electrocardiogram (ECG). * Have clinically significant abnormalities in blood pressure, pulse rate, or body temperature. * Have a current or recent acute, active infection. * Have active tuberculosis (TB), or any history of active TB.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828 | Day 1 through Day 71 |
| PK: Area Under the Concentration Versus Time Curve (AUC)(0-∞) of LY3074828 | Day 1 through Day 71 |
Countries
United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed