A Single and Multiple Ascending Dose Study of LY3876602 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

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-23

Study Completion Date

2025-09-20

Brief Summary

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The aim of this study is to evaluate the safety, tolerability and PK of LY3876602 after administering it as single ascending doses and, following a data review, proceeding to multiple ascending doses in healthy participants. Blood tests will also be performed to check how much LY3876602 gets into the bloodstream and cerebrospinal fluid (CSF) and how long it takes the body to eliminate it.

Following the screening visit for Part A, the study will last up to approximately 20 weeks., and a subgroup of participants will consent to CSF collections The study will last up to approximately 28 weeks for Part B. All participants will consent to CSF collections.

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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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LY3876602

Single ascending doses of LY3876602 administered intravenously (IV).

Group Type EXPERIMENTAL

LY3876602

Intervention Type DRUG

Administered IV.

Placebo

Placebo administered IV.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV.

LY3876602 Part B (MAD)

Multiple ascending doses of LY3876602 will be administered intravenously (IV).

Group Type EXPERIMENTAL

LY3876602

Intervention Type DRUG

Administered IV.

Placebo: Part B (MAD)

Placebo administered IV

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV.

Interventions

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LY3876602

Administered IV.

Intervention Type DRUG

Placebo

Administered IV.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female participants who are overtly healthy as determined by medical evaluation
* Have a body mass index with the range of 18 and less than or equal to (≤) 32 kilograms per square meter (kg/m²)
* Male or female participants of nonchildbearing potential

Exclusion Criteria

* Have a family history, defined as a parent or first-degree relative, of genetic neurodegenerative disorders
* Have allergies to diphenhydramine, epinephrine, or methylprednisolone
* Have serious or unstable medical conditions,
* History of skin wounding within 14 days of screening or current skin infection
* Are unwilling to stop alcohol consumption 48 hours prior to each dosing
* Have active or latent tuberculosis
* Participants in the cohorts undergoing lumbar puncture have an allergy to local anesthetics

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes