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

Eli Lilly and Company33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

LY3462817 (SC)DRUG

Administered SC.

Placebo (SC)DRUG

Administered SC.

LY3462817 (IV)DRUG

Administered IV.

Placebo (IV)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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days or any other type of medical research judged to be incompatible with this study * Have previously participated or withdrawn from this study * Have cancer or a malignant disease in the past 5 years * Have or used to have health problems or laboratory test results or ECG readings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

Locations (1)

Altasciences Clinical Los Angeles, Inc

Cypress, California, United States

Outcomes

Primary Outcomes

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

Time frame: Baseline through Week 12

Secondary Outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3462817

PK: AUC of LY3462817

Time frame: Predose on Day 1 through Day 85

PK: Maximum Concentration (Cmax) of LY3462817

PK: Cmax of LY3462817

Time frame: Predose on Day 1 through Day 85

Data from ClinicalTrials.gov

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