Phase 1
Completed N=60
A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT04548219 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab — 12.7; 11.6 micrograms per milliliter (ug/mL)
Summary
The purpose of this study is to compare two different formulations of mirikizumab in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Participants will remain in the study for about 12 weeks, after receiving study drug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab |
12.7; 11.6 | — |
| PRIMARY PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Mirikizumab |
229; 209 | — |
| PRIMARY PK: Area Under the Concentration Versus Time Curve From Time Zero to t, Where t is the Last Timepoint With a Measurable Concentration (AUC[0-tlast]) of Mirikizumab |
225; 206 | — |
Eligibility Criteria
Inclusion Criteria
- Are overtly healthy males or females, as determined through medical history and physical examination
Exclusion Criteria
- Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
- Must not show evidence of active or latent tuberculosis (TB)
- Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study
- Must not have been treated with steroids within 1 month of screening, or intend to during the study
- Must not be immunocompromised
- Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
- Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
- Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- Must not have had breast cancer within the past 10 years
- Must not have significant allergies to humanized monoclonal antibodies
- Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
Data sourced from ClinicalTrials.gov (NCT04548219). 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.