Phase 1
Completed N=67
A Study of Mirikizumab (LY3074828) Injection in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT03053622 ↗
Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab — 215; 214; 293; 695 Microgram* Day/Milliliter(µg*day/mL)
Summary
This study is conducted to compare how much mirikizumab, in two different formulations, is absorbed into the bloodstream and how long the body takes to get rid of it, when given as an injection under the skin or into the veins. Side effects of the injection will be collected. Each participant will be in the study for about 18 weeks, including screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab |
215; 214; 293; 695 | — |
| SECONDARY PK: Maximum Observed Concentration (Cmax) of Mirikizumab |
11.4; 11.2; 14.9; 90.0 | — |
| SECONDARY PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab |
73.12; 73.41; 73.25; 2.00 | — |
Eligibility Criteria
Inclusion Criteria
- Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter squared (kg/m²), inclusive
- Have medical test results that are acceptable for the study
- Must be willing to make oneself available for the whole study and be willing to follow study procedures
Exclusion Criteria
- Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
- Have known allergies to compounds or drugs similar to Mirikizumab
- Have previously participated or withdrawn from this study
- Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Data sourced from ClinicalTrials.gov (NCT03053622). 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.