A Study of LY3541860 in Healthy Japanese and Non-Japanese Participants

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the safety and tolerability of LY3541860 in healthy Japanese and non-Japanese participants. The study will also assess how fast LY3541860 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 113 days.

Official Title
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A Phase 1, Randomized, Participant- and Investigator-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3541860 in Healthy Japanese and Non-Japanese Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3541860
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are male or female not of childbearing potential Have a body weight between 18 and 32 kilograms per square meter (kg/m²) and a body weight ≥ 50 kilograms (kg) Have veins suitable for blood sampling Exclusion Criteria: Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study Have active or latent TB Have had breast cancer within the past 10 years or had lymphoma, leukemia, or any malignancy within the past 5 years Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive 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. Have previously completed a clinical trial investigating any other molecule targeting CD19, CD20 or have previously discontinued from this study after receiving LY3541860 Are currently participating in or completed a clinical trial within the last 30 days Have received a vaccine containing a live (attenuated) virus within 28 days of screening or intend to receive during the course of the study.

Ages Eligible for Study
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Minimum Age: 20 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: LY3541860 (Part A)<br>Single doses of LY3541860 administered intravenously (IV) or subcutaneously (SC). | Drug: LY3541860<br>* Administered either IV or SC.<br>|
| Experimental: LY3541860 (Part B)<br>Multiple doses of LY3541860 administered either IV or SC. | Drug: LY3541860<br>* Administered either IV or SC.<br>|
| Placebo Comparator: Placebo (Part A)<br>Single doses of Placebo administered either IV or SC. | Drug: Placebo<br>* Administered either IV or SC.<br>|
| Placebo Comparator: Placebo (Part B)<br>Multiple doses of Placebo administered either IV or SC. | Drug: Placebo<br>* Administered either IV or 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 Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Day 113 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3541860 | PK: Cmax of LY3541860 | Predose on Day 1 through Day 113 | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3541860 | PK: AUC of LY3541860 | Predose on Day 1 through Day 113 |