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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05440136
• Other study ID #: 18141
• Secondary ID: J1A-MC-KDAE
• Status: Completed
• Phase: Phase 1
• Start date: June 28, 2022
• Est. completion date: March 8, 2023

Study information

• Verified date: March 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 8, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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• Have previously participated or withdrawn from this study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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3462817 (SC)
Administered SC.
• Placebo (SC)
Administered SC.
• LY3462817 (IV)
Administered IV.
• Placebo (IV)
Administered IV.

Locations

Country	Name	City	State
United States	Altasciences Clinical Los Angeles, Inc	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3462817	PK: AUC of LY3462817	Predose on Day 1 through Day 85
Secondary	PK: Maximum Concentration (Cmax) of LY3462817	PK: Cmax of LY3462817	Predose on Day 1 through Day 85