A Study of Mirikizumab (LY3074828) Injection in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Single-Dose Study to Assess the Relative Bioavailability, Absolute Bioavailability, and Tolerability of LY3074828 Formulations in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Biological: Mirikizumab Test
* Biological: Mirikizumab Test
* Biological: Mirikizumab Reference


Participation Criteria
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Eligibility Criteria
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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with this study Have known allergies to compounds or drugs similar to Mirikizumab Have previously participated or withdrawn from this study Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirikizumab Test Subcutaneous (SC) 1<br>Mirikizumab test formulation given as a single injection under the skin in healthy participants | Biological: Mirikizumab Test<br>* Administered SC<br>* Other names: LY3074828;|
| Experimental: Mirikizumab Test SC 2<br>Mirikizumab test formulation given as two injections under the skin in healthy participants | Biological: Mirikizumab Test<br>* Administered SC<br>* Other names: LY3074828;|
| Experimental: Mirikizumab Test Intravenous (IV)<br>Mirikizumab test formulation given as an infusion into the vein in healthy participants | Biological: Mirikizumab Test<br>* Administered IV<br>* Other names: LY3074828;|
| Active Comparator: Mirikizumab Reference<br>Mirikizumab reference formulation given as three injections under the skin in healthy participants | Biological: Mirikizumab Reference<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): Area Under the Concentration Versus Time Curve (AUC) of Mirikizumab | PK: AUC of Mirikizumab | Baseline to at least 29 days following administration of mirikizumab on Day 1 of each study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: Maximum Observed Concentration (Cmax) of Mirikizumab | PK: Cmax of Mirkizumab | Baseline to at least 29 days following administration of Mirikizumab on Day 1 of each study period | 
| PK: Time of Cmax (Tmax) of Mirikizumab | PK: Tmax of Mirikizumab | Baseline to at least 29 days following administration of Mirikizumab on Day 1 of each study period |