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Official title A Study of Mirikizumab Solution (LY3074828) in Healthy Participants
ClinicalTrials.gov ID: NCT07446101
What this study is testing
What is Mirikizumab?
Mirikizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy.
Also referred to as LY3074828.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Are overtly healthy males or females as determined by medical evaluation including:
- medical history
- physical examination
- clinical laboratory tests
- ECG, and
You likely can't join if
- Have significant allergies to humanized monoclonal antibodies or known allergies to mirikizumab, related compounds or any components of the...
- 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...
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Daytona Beach, Florida, United States
- Dilworth, Minnesota, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Daytona Beach, Florida, United States; Dilworth, Minnesota, United States; Dallas, Texas, United States; San Antonio, Texas, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.