A Safety Study of LY3462817 in Healthy Japanese and Non-Japanese Participants

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the safety and tolerability of LY3462817 in healthy Japanese and non-Japanese participants. The study will also assess how fast LY3462817 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 12 weeks.

Official Title
-----------------
A Single-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3462817 in Healthy Japanese and Non-Japanese Participants

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: LY3462817 (SC)
* Drug: Placebo (SC)
* Drug: LY3462817 (IV)
* Drug: Placebo (IV)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are overtly healthy as determined by medical evaluation Japanese participants must be first generation Japanese and have a body mass index (BMI) of 18.0 to 30.0 kilograms per square meter (kg/m²) (inclusive), and a body weight of 45 and 85 kg (inclusive) Non-Japanese participants have a BMI of 18.0 to 32.0 kg/m² (inclusive), and a minimum body weight of 45 kg Are males who agree to follow contraception requirements or females not of childbearing potential Have blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study Exclusion Criteria: Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study Have previously participated or withdrawn from this study Have cancer or a malignant disease in the past 5 years Have or used to have health problems or laboratory test results or ECG readings that, in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 Are unwilling to receive study drug administration by injections or through the veins

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3462817 - SC<br>LY3462817 administered subcutaneously (SC) | Drug: LY3462817 (SC)<br>* Administered SC.<br>|
| Experimental: LY3462817 - IV<br>LY3462817 administered intravenously (IV) | Drug: LY3462817 (IV)<br>* Administered IV.<br>|
| Placebo Comparator: Placebo - SC<br>Placebo administered SC | Drug: Placebo (SC)<br>* Administered SC.<br>|
| Placebo Comparator: Placebo - IV<br>Placebo administered IV | Drug: Placebo (IV)<br>* Administered IV.<br>|

What is the study measuring?
-----------------
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 Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3462817 | PK: AUC of LY3462817 | Predose on Day 1 through Day 85 | 
| PK: Maximum Concentration (Cmax) of LY3462817 | PK: Cmax of LY3462817 | Predose on Day 1 through Day 85 |