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A Study of Mirikizumab in Healthy Participants

This study is looking for healthy volunteers aged 18 to 65 to help us understand how a medicine called mirikizumab (LY3074828) works in the body. Mirikizumab is given as an injection under the skin. We want to see if giving it as a single injection is as safe and well-tolerated as giving it as two injections. We will take blood samples to measure how your body processes mirikizumab. To join, you must be in good health, have normal lab test results, and a body mass index (BMI) between 18.0 and 34. The study will last about 15 weeks for each participant. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 450 healthy participants. It compares a single injection of mirikizumab to two injections.
What's involved
You would receive mirikizumab injections and have blood tests. The study will last about 15 weeks for each participant.
Compensation
Not stated in the trial record.
Follow-up
Blood tests to measure mirikizumab levels will be taken from Day 1 through Day 71 after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07446101

A Study of Mirikizumab Solution (LY3074828) in Healthy Participants

Recruiting
PHASE1Ages 18–65InterventionalBasic science
Eli Lilly and Company
~450 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Mirikizumab

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828
Measured over Day 1 through Day 71
+1 more outcome measured

Conditions

Healthy

Explore related trials

Healthy

Where it's being run

5 sites across 4 states
Texas2
Florida1
Minnesota1
Wisconsin1

Study leadership

  • 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) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828Day 1 through Day 71
  • PK: Area Under the Concentration Versus Time Curve (AUC)(0-∞) of LY3074828Day 1 through Day 71