A Study of Mirikizumab Solution (LY3074828) in Healthy Participants (NCT07446101) | Clinical Trial Compass
RecruitingPhase 1
A Study of Mirikizumab Solution (LY3074828) in Healthy Participants
United States450 participantsStarted 2026-03-24
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tu…
What they're measuring
1
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828
Timeframe: Day 1 through Day 71
2
PK: Area Under the Concentration Versus Time Curve (AUC)(0-∞) of LY3074828
Timeframe: Day 1 through Day 71
Trial details
NCT IDNCT07446101
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-02
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or