A Study of LY3090106 in Japanese and Caucasian Healthy 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 a study drug known as LY3090106 in healthy Caucasian and Japanese participants. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug. The study will last about 12 weeks, not including screening or additional follow-up.

Official Title
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A Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3090106 in Japanese and Caucasian Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3090106
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy Japanese or Caucasian Body mass index (BMI) 18.0 - 32.0 kilograms per square meter (kg/m²) Exclusion Criteria: Have participated, within the last 30 days, in a clinical study involving an investigational product (IP). If the previous IP has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed Have had symptomatic herpes zoster within 3 months of screening Show evidence of active or latent tuberculosis (TB) Have known hypogammaglobulinemia or a screening serum immunoglobulin (Ig) G <565 milligrams per deciliter (mg/dL) Have received live or attenuated 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. Participants with any prior exposure to ixekizumab, tabalumab or other biologic agents directly targeting Interleukin 17 (IL-17) and/or B cells (e.g., rituximab, belimumab, etc.) are excluded

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: LY3090106<br>LY3090106 administered subcutaneously (SC) | Drug: LY3090106<br>* Administered SC<br>|
| Placebo Comparator: Placebo<br>Placebo administered SC | Drug: Placebo<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 |
| --- | --- | --- |
| Maximum Observed Drug Concentration (Cmax) of LY3090106 | Cmax of LY3090106 | Baseline through Day 85 | 
| Area Under the Concentration-Versus-Time Curve (AUC) of LY3090106 | AUC of LY3090106 | Baseline through Day 85 |