A Study of Mirikizumab Solution (LY3074828) in Healthy Participants
Recruiting
Phase 1Interventional Study
Healthy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
450 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for healthy men and women to test a new injection. Participants will receive either one or two injections and will be monitored over about 15 weeks.
Are You a Good Fit for This Trial?
Rules you outActive tuberculosis
You may be able to join if
I am healthy as confirmed by a medical check-up.
I have normal lab test results.
My BMI is between 18.0 and 34.0.
You may not be able to join if
I have serious allergies to certain proteins or medications.
I have a history of significant health issues that affect drug processing.
I am immunocompromised.
I plan to take any medications in the week before treatment.
I have had any biologic treatments in the last 3 months.
I have received mirikizumab before.
I have an abnormal ECG result.
I have a current or recent serious infection.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 Locations
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Status
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…
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.
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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