A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants
Completed · Phase 1
Conditions studied: Healthy
In brief
The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via pre-filled syringe compared to mirikizumab (reference) solution given via pre-filled syringe. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated. Screening is required within 35 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.
Key facts
- Study ID
- NCT05644353
- Run by
- Eli Lilly and Company
- People needed
- 450
- Starts
- 2022-12-05
- Expected to finish
- 2023-05-25
- Last updated by the study team
- 2025-03-28
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Participants who are overtly healthy as determined by medical evaluation
- Have a body mass index( BMI) within the range of 18.0 to 34.0 kg/m2, inclusive.
- Are males or non-pregnant women of childbearing potential (WOCBP) or women not of childbearing potential (WNOCBP).
You may not qualify if…
- 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 an abnormal blood pressure, pulse rate, or temperature as determined by the investigator
- Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing
- Are lactating or pregnant
Where it is running
- Altasciences Clinical Los Angeles, Inc — Cypress, California, United States
- LabCorp CRU, Inc. — Daytona Beach, Florida, United States
- Clinical Pharmacology of Miami — Miami, Florida, United States
- Qps-Mra, Llc — Miami, Florida, United States
- Axis — Dilworth, Minnesota, United States
- Labcorp Clinical Research LP — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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