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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-28

Study Completion Date

2023-03-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3462817 - SC

LY3462817 administered subcutaneously (SC)

Group Type EXPERIMENTAL

LY3462817 (SC)

Intervention Type DRUG

Administered SC.

LY3462817 - IV

LY3462817 administered intravenously (IV)

Group Type EXPERIMENTAL

LY3462817 (IV)

Intervention Type DRUG

Administered IV.

Placebo - SC

Placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo (SC)

Intervention Type DRUG

Administered SC.

Placebo - IV

Placebo administered IV

Group Type PLACEBO_COMPARATOR

Placebo (IV)

Intervention Type DRUG

Administered IV.

Interventions

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LY3462817 (SC)

Administered SC.

Intervention Type DRUG

Placebo (SC)

Administered SC.

Intervention Type DRUG

LY3462817 (IV)

Administered IV.

Intervention Type DRUG

Placebo (IV)

Administered IV.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes