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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3876602; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06007638

18734

J4K-MC-LALA (Other Identifier)

2023-504838-21-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 4 patient groups, including a placebo group

LY3876602

Experimental group

Description:

Single ascending doses of LY3876602 administered intravenously (IV).

Treatment:

Drug: LY3876602

Placebo

Placebo Comparator group

Description:

Placebo administered IV.

Treatment:

Drug: Placebo

LY3876602 Part B (MAD)

Experimental group

Description:

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

Treatment:

Drug: LY3876602

Placebo: Part B (MAD)

Placebo Comparator group

Description:

Placebo administered IV

Treatment:

Drug: Placebo