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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3462817 (IV); Drug: LY3462817 (SC); Drug: Placebo (IV); Drug: Placebo (SC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05440136

18141

J1A-MC-KDAE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously participated or withdrawn from this study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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

33 participants in 4 patient groups, including a placebo group

LY3462817 - SC

Experimental group

Description:

LY3462817 administered subcutaneously (SC)

Treatment:

Drug: LY3462817 (SC)

LY3462817 - IV

Experimental group

Description:

LY3462817 administered intravenously (IV)

Treatment:

Drug: LY3462817 (IV)

Placebo - SC

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo (SC)

Placebo - IV

Placebo Comparator group

Description:

Placebo administered IV

Treatment:

Drug: Placebo (IV)