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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3462817 (SC); Drug: LY3462817 (IV); Drug: Placebo (SC); Drug: Placebo (IV)

• Registration Number: NCT05440136
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study Start: 2022-06-28
• Study First Posted: 2022-06-30
• Status Verified: 2023-03
• Primary Completion: 2023-03-08
• Study Completion: 2023-03-08
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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• Have previously participated or withdrawn from this study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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3462817 - SC	LY3462817 (SC)	LY3462817 administered subcutaneously (SC)
LY3462817 - IV	LY3462817 (IV)	LY3462817 administered intravenously (IV)
Placebo - SC	Placebo (SC)	Placebo administered SC
Placebo - IV	Placebo (IV)	Placebo administered IV

Primary Outcome Measures

Name	Time	Method
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	Baseline through Week 12	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
PK: Maximum Concentration (Cmax) of LY3462817	Predose on Day 1 through Day 85	PK: Cmax of LY3462817
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3462817	Predose on Day 1 through Day 85	PK: AUC of LY3462817

Trial Locations

Locations (1)

Altasciences Clinical Los Angeles, Inc; 🇺🇸 Cypress, California, United States