A Study of Mirikizumab in Healthy Chinese Participants

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the safety of the study drug known as mirikizumab. The study will investigate how the body processes the study drug. It will last up to about 4 months for each participant.

Official Title
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A Single-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3074828 in Healthy Chinese 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: Native Chinese (all 4 biological grandparents and both biological parents to be Chinese origin) Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, at time of screening Have clinical laboratory test results within normal reference range for the investigative site or results with acceptable deviations that are judged to be not clinically significant by the investigator Have venous access sufficient to allow for blood sampling and administration of investigational product (IP) or placebo Are reliable and willing to be available for the duration of the study and are willing to follow study procedures Are able and willing to give signed informed consent Exclusion Criteria: Are currently enrolled in a clinical study involving an IP or any other type of medical research judged not to be scientifically or medically compatible with this study Have participated in a clinical trial involving an IP within 30 days or 5 half-lives (whichever is longer) prior to screening. If the clinical trial involved treatment with biologic agents (such as monoclonal antibodies, including marketed drugs), at least 3 months or 5 half-lives (whichever is longer) should have elapsed prior to Day 1 Have known allergies to LY3074828, humanized monoclonal antibodies, related compounds or any components of the formulation, or history of significant atopy Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies Show evidence of hepatitis C and/or positive hepatitis C antibody Show evidence of hepatitis B and/or positive hepatitis B surface antigen or positive hepatitis B core antibody Have had symptomatic herpes zoster within 3 months of screening Show evidence of active or latent tuberculosis (TB), as documented by medical history, examination, chest X-rays (posterior/anterior and lateral), and TB testing (positive or indeterminate for QuantiFERON® -TB Gold test or T-Spot. 1 retest permitted following indeterminate result); or have had household contact with a person with active TB, unless appropriate and documented prophylaxis treatment has been given. Participants with any history of active TB are excluded from the study, regardless of previous or current TB treatments. Have received live vaccine(s), including attenuated live vaccines and those administered intranasally, within 8 weeks of screening, or intend to during the study Are immunocompromised Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirikizumab - Intravenous (IV)<br>Mirikizumab administered IV | Drug: Mirikizumab - IV<br>* Administered IV<br>* Other names: LY3074828;|
| Placebo Comparator: Placebo - IV<br>Placebo administered IV | Drug: Placebo - IV<br>* Administered IV<br>|
| Experimental: Mirikizumab - Subcutaneous (SC)<br>Mirikizumab administered SC | Drug: Mirikizumab - SC<br>* Administered SC<br>* Other names: LY3074828;|
| Placebo Comparator: Placebo - SC<br>Placebo administered SC | 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 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab | PK: Cmax of Mirikizumab | Baseline through Day 85 | 
| PK: AUC from time zero to infinity (AUC[0-∞]) of Mirikizumab | PK: AUC(0-∞) of Mirikizumab | Baseline through Day 85 | 
| PK: AUC from Time Zero to Time T, where T is the Last Sample with a Measurable Concentration (AUC[0-tlast]) of Mirikizumab | PK: AUC(0-tlast) of Mirikizumab | Baseline through Day 85 |