A Safety Study of LY3462817 in Healthy Participants

Eli Lilly and Company64 enrolled

Overview

This study is being conducted to determine how safe and how well tolerated LY3462817 is when given intravenously (IV) (into a vein) and subcutaneously (SC) (just under the skin) to healthy participants. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive 1 dose of LY3462817 or placebo. The study will last about 16 weeks, including screening.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

LY3462817 IVBIOLOGICAL

Administered IV

LY3462817 SCBIOLOGICAL

Administered SC

PlaceboDRUG

Administered IV

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Overtly healthy male or a female who cannot get pregnant * Have a body mass index (BMI) of 18 to 32 kilogram per square meter (kg/m²), inclusive, at screening * Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study * Weight at least 45 kilograms (kg) 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days or any other type of medical research judged to be incompatible with this study * Have previously participated or withdrawn from this study * Have cancer or a malignant disease in the past 5 years * Have or used to have health problems or laboratory test results or ECG readings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)

Lilly Nus Centre for Clin Pharmacology

Singapore, Singapore

Outcomes

Primary Outcomes

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Time frame: Baseline through to final follow-up at approximately Week 12

Secondary Outcomes

Pharmacokinetics: Maximum Concentration (Cmax) of LY3462817

Pharmacokinetics: Cmax of LY3462817

Time frame: Baseline through to final follow-up at approximately Week 12

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

Pharmacokinetics: AUC of LY3462817

Time frame: Baseline through to final follow-up at approximately Week 12

Data from ClinicalTrials.gov

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