A Study of Mirikizumab Solution (LY3074828) in Healthy Participants

NCT07446101
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
450
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Lead sponsor
Eli Lilly and Company
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Start date
2026-03-24
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Number of sites
5
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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.
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Short title
A Study of Mirikizumab Solution (LY3074828) in Healthy Participants
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Official title
An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution in Healthy Participants
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-02-01
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First posted
2026-03-03
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Registry last updated
2026-05-14
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Primary completion date
2027-02-01
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Start date
2026-03-24
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Participants
450
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Participant count basis
Estimated
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Planned participants
450
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Protocol amendments
0
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Number of sites
5
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07446101
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ClinicalTrials.gov ID
NCT07446101
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Basic science
Masking
No masking
Sources for study design
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  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
Yes

  • 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.

  • 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
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  • 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
clinicaltrials.gov

Other registry identifiers

  • I6T-MC-AMCG
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (2)