A Single and Multiple Ascending Dose Study of LY3876602 in Healthy Participants

NCT06007638 | Completed Phase 1

• 3 other identifiers: 18734J4K-MC-LALA2023-504838-21-00
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline up to 28 weeks

Secondary Outcomes (3)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3876602

  Predose up to 28 weeks

• PK: Maximum Observed Drug Concentration (Cmax) of LY3876602

  Predose up to 28 weeks

• PK: Half-life (t1/2) of LY3876602

  Predose up to 28 weeks

Study Arms (4)

LY3876602

EXPERIMENTAL

Single ascending doses of LY3876602 administered intravenously (IV).

Drug: LY3876602

Placebo

PLACEBO COMPARATOR

Placebo administered IV.

Drug: Placebo

LY3876602 Part B (MAD)

EXPERIMENTAL

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

Drug: LY3876602

Placebo: Part B (MAD)

PLACEBO COMPARATOR

Placebo administered IV

Drug: Placebo

Interventions

LY3876602 DRUG

Administered IV.

LY3876602; LY3876602 Part B (MAD)

Placebo DRUG

Administered IV.

Placebo; Placebo: Part B (MAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

ICON Early Phase Services, LLC

Groningen, 9728 NZ, Netherlands

Location

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 23, 2023
• Study Start: August 23, 2023
• Primary Completion: September 20, 2025
• Study Completion: September 20, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)