A Study of Mirikizumab Solution (LY3074828) in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mirikizumab.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution in Healthy Participants
Overview
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.
Interventions
- Drug Mirikizumab
Administered SC
Primary outcome measures
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828 [Time frame: Day 1 through Day 71]
- PK: Area Under the Concentration Versus Time Curve (AUC)(0-∞) of LY3074828 [Time frame: Day 1 through Day 71]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 5 centers
- Fortrea Clinical Research Unit — Daytona Beach
- Axis Clinicals LLC — Dilworth
- Fortrea Clinical Research Unit — Dallas
- Worldwide Clinical Trials, Inc. — San Antonio
- Fortrea Clinical Research Unit — Madison
Identifiers
NCT: NCT07446101 · 27403 · I6T-MC-AMCG