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

Phase 1

Active, not recruiting

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LY3876602

• Registration Number: NCT06007638
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-08-18
• Study Start: 2023-08-23
• Study First Posted: 2023-08-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered IV.
LY3876602	LY3876602	Single ascending doses of LY3876602 administered intravenously (IV).
LY3876602 Part B (MAD)	LY3876602	Multiple ascending doses of LY3876602 will be administered intravenously (IV).
Placebo: Part B (MAD)	Placebo	Placebo administered IV

Primary Outcome Measures

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

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3876602	Predose up to 28 weeks	PK: AUC of LY3876602
PK: Maximum Observed Drug Concentration (Cmax) of LY3876602	Predose up to 28 weeks	PK: Cmax of LY3876602
PK: Half-life (t1/2) of LY3876602	Predose up to 28 weeks	PK: t1/2 of LY3876602

Trial Locations

Locations (1)

ICON Early Phase Services, LLC; 🇳🇱 Groningen, Netherlands