A Study of Mirikizumab Solution (LY3074828) in Healthy Participants

Purpose

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.

Condition

  • Healthy

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Fortrea Clinical Research Unit
Daytona Beach, Florida 32117
Contact:
866-429-3700

Axis Clinicals LLC
Dilworth, Minnesota 56560
Contact:
218-284-2947, Option 2

Fortrea Clinical Research Unit
Dallas, Texas 75247
Contact:
866-429-3700

Worldwide Clinical Trials, Inc.
San Antonio, Texas 78217
Contact:
210-635-1500

Fortrea Clinical Research Unit
Madison, Wisconsin 53704
Contact:
866-429-3700

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com