A Study of LY3876602 in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06007638

Collaborator

(none)

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3876602 after administering as single ascending doses and following a data review proceeding to multiple ascending doses in healthy participants. The 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.

The study will last up to approximately 17 weeks. A subgroup of participants will be consented for CSF collections.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3876602 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official 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

Anticipated Study Start Date :

Aug 22, 2023

Anticipated Primary Completion Date :

Feb 18, 2025

Anticipated Study Completion Date :

Feb 18, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3876602 Single ascending doses of LY3876602 administered intravenously (IV).	Drug: LY3876602 Administered IV.
Placebo Comparator: Placebo Placebo administered IV.	Drug: Placebo Administered IV.

Arm

Intervention/Treatment

Experimental: LY3876602

Single ascending doses of LY3876602 administered intravenously (IV).

Drug: LY3876602

Administered IV.

Placebo Comparator: Placebo

Placebo administered IV.

Drug: Placebo

Administered IV.

Outcome Measures

Primary Outcome Measures

Part A: 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 17 weeks]
Part A: 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

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3876602 [Predose up to 17 weeks]
PK: AUC of LY3876602
PK: Maximum Observed Drug Concentration (Cmax) of LY3876602 [Predose up to 17 weeks]
PK: Cmax of LY3876602
PK: Half-life (t1/2) of LY3876602 [Predose up to 17 weeks]
PK: t1/2 of LY3876602

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pharmaceutical Research Associates Group B.V.	Groningen		Netherlands	9728

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT06007638

Other Study ID Numbers:

18734
J4K-MC-LALA
2023-504838-21

First Posted:

Aug 23, 2023

Last Update Posted:

Aug 23, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 23, 2023