A Study of Mirikizumab (LY3074828) in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to explore the safety and tolerability of mirikizumab in healthy Japanese and Caucasian participants. The study will also estimate how much mirikizumab gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 16 weeks for each participant.

Official Title
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A Single-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3074828 in Japanese and Caucasian Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Mirikizumab - IV
* Drug: Mirikizumab - SC
* Drug: Placebo - IV
* Drug: Placebo - SC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy males or females, as determined by medical history and physical examination. Are first generation Japanese or are Caucasian. Have a body mass index (BMI) of 18.0 kilograms per square meter (kg/m2) to 32.0 kg/m2, inclusive, at screening. Have a body weight of 40.0 kg or higher for Cohorts 1, 2, 3 and 4, and 48.0 kg or higher for Cohort 5. Exclusion Criteria: Have had symptomatic herpes zoster within 3 months of screening. Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-rays (posterior anterior and lateral), and TB testing. Have received live vaccine(s) within 1 month of screening or intend to during the study. Are immunocompromised. Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 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 IV<br>Mirikizumab given by intravenous (IV) infusion once. | Drug: Mirikizumab - IV<br>* Administered IV<br>* Other names: LY3074828;|
| Experimental: Mirikizumab SC<br>Mirikizumab given by subcutaneous (SC) injection once. | Drug: Mirikizumab - SC<br>* Administered SC<br>* Other names: LY3074828;|
| Placebo Comparator: Placebo IV<br>Placebo given by IV infusion once. | Drug: Placebo - IV<br>* Administered IV<br>|
| Placebo Comparator: Placebo SC<br>Placebo given by SC injection once. | Drug: Placebo - SC<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |  | Baseline through Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) of Mirikizumab |  | Baseline through Day 85 | 
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of Mirikizumab |  | Baseline through Day 85 |