Phase 1
Completed N=396
A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT05515601 ↗
Enrolled (actual)
396
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab — 13.0; 12.9 micrograms per milliliter (μg/mL)
Summary
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 autoinjector compared to mirikizumab (reference) solution given via autoinjector. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab |
13.0; 12.9 | — |
| PRIMARY PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab |
229; 232 | — |
| PRIMARY PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab |
225; 231 | — |
Eligibility Criteria
Inclusion Criteria
- 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).
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 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
Data sourced from ClinicalTrials.gov (NCT05515601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.