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

An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution in Healthy Participants

This trial will test if a single injection of mirikizumab solution is as safe and well-tolerated as two subcutaneous injections in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Eli Lilly and Company (Industry-sponsored)
• Drugs / interventions: mirikizumab
• Locations: 5 sites (Daytona Beach, Florida and 4 other locations)
• Trial ID: NCT07446101 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Healthy adults who pass medical screening, have a BMI of 18.0–34.0 kg/m2, normal laboratory and ECG results, and no significant allergies to monoclonal antibodies or immunocompromise are eligible.

Not a fit: People who are immunocompromised, have significant allergies to monoclonal antibodies, abnormal screening labs, major comorbidities affecting drug handling, or who seek direct therapeutic benefit for a medical condition are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could allow a single injection instead of two, simplifying administration and improving convenience for future patients.

How similar studies have performed: Previous phase 1 work with mirikizumab and other monoclonal antibodies has generally shown predictable pharmacokinetics and acceptable safety, so formulation and injection-number comparisons are a common development step.

Eligibility criteria

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 this trial is running

Daytona Beach, Florida and 4 other locations

• 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

Conditions Healthy