Mirikizumab single versus two under-the-skin injections in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial compares a single subcutaneous injection of mirikizumab solution with two subcutaneous injections in healthy adult volunteers over about 15 weeks per participant. The primary focus is on safety and tolerability, with blood tests to measure how the body processes the drug (pharmacokinetics). Participants will undergo medical screening including labs, ECG, and vital signs before dosing and will return for scheduled follow-up visits. The work is being conducted at three US clinical research units under Eli Lilly sponsorship.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fortrea Clinical Research Unit
  Daytona Beach, Florida, United States Recruiting
• Axis Clinicals LLC
  Dilworth, Minnesota, United States Recruiting
• Fortrea Clinical Research Unit
  Dallas, Texas, United States Recruiting
• Worldwide Clinical Trials, Inc.
  San Antonio, Texas, United States Recruiting
• Fortrea Clinical Research Unit
  Madison, Wisconsin, United States Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.