NCT07446101

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_1 healthy

Timeline
8mo left

Started Mar 2026

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Feb 2027

First Submitted

Initial submission to the registry

February 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

March 24, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

February 26, 2026

Last Update Submit

May 13, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Mirikizumab (Test Arm 1)

EXPERIMENTAL

Mirikizumab administered subcutaneously (SC)

Drug: Mirikizumab

Mirikizumab (Test Arm 2)

EXPERIMENTAL

Mirikizumab administered SC

Drug: Mirikizumab

Mirikizumab (Reference Arm)

EXPERIMENTAL

Mirikizumab administered SC

Drug: Mirikizumab

Interventions

MirikizumabDRUG

Administered SC

Also known as: LY3074828
Mirikizumab (Reference Arm)Mirikizumab (Test Arm 1)Mirikizumab (Test Arm 2)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

RECRUITING

Axis Clinicals LLC

Dilworth, Minnesota, 56529, United States

RECRUITING

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

RECRUITING

Worldwide Clinical Trials, Inc.

San Antonio, Texas, 78217, United States

RECRUITING

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

RECRUITING

MeSH Terms

Interventions

mirikizumab

Study Officials

  • 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 DIRECTOR

Central Study Contacts

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

CONTACT

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

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 3, 2026

Study Start

March 24, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(5)