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OpenTrials
Completed

NCT Number: NCT06007638

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

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services, LLC

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3876602

Drug

Administered IV.

Placebo

Drug

Administered IV.

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

    Time frame: Baseline up to 28 weeks

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

Secondary outcomes

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

    Time frame: Predose up to 28 weeks

    PK: AUC of LY3876602

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY3876602

    Time frame: Predose up to 28 weeks

    PK: Cmax of LY3876602

  3. PK: Half-life (t1/2) of LY3876602

    Time frame: Predose up to 28 weeks

    PK: t1/2 of LY3876602

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomised Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3876602 in Healthy Participants

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2023
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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