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NCT Number: NCT07446101

A Study of Mirikizumab Solution (LY3074828) in Healthy Participants

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.

Recruiting

Interested in participating?

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit, Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mirikizumab

Drug

Administered SC

Other names: LY3074828

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828

    Time frame: Day 1 through Day 71

  2. PK: Area Under the Concentration Versus Time Curve (AUC)(0-∞) of LY3074828

    Time frame: Day 1 through Day 71

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution in Healthy Participants

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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