A Study of Mirikizumab Solution (LY3074828) in Healthy Participants

An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution 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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Mirikizumab

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Recruiting
      • Fortrea Clinical Research Unit
      • Principal Investigator: Kathleen Doisy
      • Contact: Phone Number: 866-429-3700
  • Minnesota
    • Dilworth, Minnesota, United States, 56529
      • Recruiting
      • Axis Clinicals LLC
      • Principal Investigator: John Mickelson
      • Contact: Phone Number: 218-284-2947, Option 2
  • Texas
    • Dallas, Texas, United States, 75247
      • Recruiting
      • Fortrea Clinical Research Unit
      • Principal Investigator: Archie Bowie
      • Contact: Phone Number: 866-429-3700
    • San Antonio, Texas, United States, 78217
      • Recruiting
      • Worldwide Clinical Trials, Inc.
      • Principal Investigator: Alan Hand
      • Contact: Phone Number: 210-635-1500
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Recruiting
      • Fortrea Clinical Research Unit
      • Principal Investigator: Kimberly Cruz
      • Contact: Phone Number: 866-429-3700

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mirikizumab (Test Arm 1); Mirikizumab administered subcutaneously (SC)	Drug: Mirikizumab; Administered SC; Other Names: LY3074828
Experimental: Mirikizumab (Test Arm 2); Mirikizumab administered SC	Drug: Mirikizumab; Administered SC; Other Names: LY3074828
Experimental: Mirikizumab (Reference Arm); Mirikizumab administered SC	Drug: Mirikizumab; Administered SC; Other Names: LY3074828

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: mirikizumab
• Other Study ID Numbers: 27403; I6T-MC-AMCG (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No