A First-In-Human Study of LY3985297 in Healthy 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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-07

Study Completion Date

2025-08-06

Brief Summary

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The main purpose of this study is to see if LY3985297, the study drug, is safe and well-tolerated when given as a single dose or as multiple doses either through an intravenous (into a vein) or a subcutaneous (under the skin) injection in healthy participants. Study will also evaluate how much of the study drug LY3985297 gets into the blood stream and how long it takes the body to remove it.

The study is conducted in two parts (part A and B), each part has a separate treatment cohort.

The study will last up to approximately 116 days for part A, and 145 days for part B, including the screening period.

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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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Part A: LY3985297 (Cohorts 1-8)

Single ascending dose of LY3985297 administered either intravenously (IV) or subcutaneously (SC). Cohort 5,6 and 7 is conducted in Japanese or Chinese participants.

Group Type EXPERIMENTAL

LY3985297

Intervention Type DRUG

Administered either IV or SC.

Part B: LY3985297 (Cohorts 1-4)

Multiple ascending dose of LY3985297 administered either IV or SC.

Group Type EXPERIMENTAL

LY3985297

Intervention Type DRUG

Administered either IV or SC.

Placebo Comparator: Part A and B: Placebo

Placebo administered either IV or SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered either IV or SC.

Interventions

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LY3985297

Administered either IV or SC.

Intervention Type DRUG

Placebo

Administered either IV or SC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants must be overtly healthy, as determined by medical evaluation.
* Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, and a minimum body weight of 45.0 kg.
* Participants must be assigned male or female at birth and not of childbearing potential.
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), clinical laboratory test results that are acceptable for the study.
* Have venous access sufficient to allow for blood sampling.

For Part A Cohorts 5, 6, and 7:

* Participants must be first-generation Japanese only, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan. Or
* Participants must be first-generation Chinese only, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Chinese descent and born in China.

Exclusion Criteria

* Have a current or recent acute, active infection. For at least 30 days before screening and up to the randomization visit (Day 1).
* Had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to screening or intend to during the study.
* Have a history of multiple or severe allergies, or an anaphylactic reaction, to prescription or nonprescription drugs or food.
* Show evidence of active or latent tuberculosis (TB).
* Have one of the following infections: hepatitis B, C virus or human immunodeficiency virus (HIV).

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes