A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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Relative Bioavailability of a Mirikizumab Test Formulation Compared to the Reference Formulation in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Mirikizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirikizumab (Reference)<br>Reference formulation of mirikizumab administered as a subcutaneous (SC) injection. | Drug: Mirikizumab<br>* Administered SC.<br>* Other names: LY3074828;|
| Experimental: Mirikizumab (Test)<br>Test formulation of mirikizumab administered as a SC injection. | Drug: Mirikizumab<br>* Administered SC.<br>* Other names: LY3074828;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | PK: Cmax of Mirikizumab | Predose on Day 1 through Day 85 | 
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Mirikizumab | PK: AUC(0-inf) of Mirikizumab | Predose on Day 1 through Day 85 |