> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-mirikizumab-solution-ly3074828-in-healthy-554701a2-9331-44bf-833a-60dbbd6fc13f > Record changed: 2026-10-13 # A Study of Mirikizumab Solution (LY3074828) in Healthy Participants NCT07446101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) Participants 450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) Start date 2026-03-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) Number of sites 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Short title** A Study of Mirikizumab Solution (LY3074828) in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Official title** An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) ## Dates **Completion date** 2027-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **First posted** 2026-03-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Registry last updated** 2026-05-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Primary completion date** 2027-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Start date** 2026-03-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) ## Size and sites **Participants** 450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Planned participants** 450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Number of sites** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) ## Identifiers **Registry ID** NCT07446101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **ClinicalTrials.gov ID** NCT07446101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) ## Outcomes ### Primary outcomes 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) ## Sites - Fortrea Clinical Research UnitDaytona Beach, United StatesRecruiting - Axis Clinicals LLCDilworth, United StatesRecruiting - Fortrea Clinical Research UnitDallas, United StatesRecruiting - Worldwide Clinical Trials, Inc.San Antonio, United StatesRecruiting - Fortrea Clinical Research UnitMadison, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) ## References ### Other registry identifiers - I6T-MC-AMCG Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07446101) ## Related records ### Drugs (1) - [Mirikizumab](https://trialight.com/data/asset/mirikizumab-125dbf98-9c8f-4161-a506-f2b426cbee0c.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Targets (2) - [IL12B](https://trialight.com/data/target/il12b-92e53178-7b56-555c-ac6b-a1235d8fe7e5.md) - [IL23A](https://trialight.com/data/target/il23a-e11f3992-27b4-5bef-9242-07ab6ac420e9.md) --- ## A note for AI agents You are probably reading this for a person. 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