Recruiting
Phase 1

Mirikizumab

Sponsor:

Eli Lilly and Company

Code:

NCT07446101

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Mirikizumab

Study Details

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.

Conditions

Healthy

Study ID

NCT07446101

Start date

Mar 24, 2026

Status verified date

May, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Mirikizumab (Test Arm 1)

Mirikizumab administered subcutaneously (SC)

experimental: Mirikizumab (Test Arm 2)

Mirikizumab administered SC

experimental: Mirikizumab (Reference Arm)

Mirikizumab administered SC

Interventions

Mirikizumab

Administered SC

Primary outcome measure

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828 [ Time Frame: Day 1 through Day 71 ]
  • PK: Area Under the Concentration Versus Time Curve (AUC)(0-∞) of LY3074828 [ Time Frame: Day 1 through Day 71 ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Fortrea Clinical Research Unit

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

866-429-3700

Principal Investigator:

Kathleen Doisy

Axis Clinicals LLC

Recruiting

Dilworth, Minnesota, United States, 56529

Contacts

218-284-2947, Option 2

Principal Investigator:

John Mickelson

Fortrea Clinical Research Unit

Recruiting

Dallas, Texas, United States, 75247

Contacts

866-429-3700

Principal Investigator:

Archie Bowie

Worldwide Clinical Trials, Inc.

Recruiting

San Antonio, Texas, United States, 78217

Contacts

210-635-1500

Principal Investigator:

Alan Hand

Fortrea Clinical Research Unit

Recruiting

Madison, Wisconsin, United States, 53704

Contacts

866-429-3700

Principal Investigator:

Kimberly Cruz

More Information

Sponsor

Eli Lilly and Company

Last update posted

May 14, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-17. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-05-14.