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RECRUITING
NCT06565195
PHASE1

A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease

Sponsor: Prevail Therapeutics

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability, and PK/PD of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study will be comprised of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Doses (MAD) study. During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid (aCSF), no active drug) given into the spinal fluid. During the MAD portion of the study, patients with Parkinson's disease will receive two doses of either LY3962681 or placebo (aCSF) administered into the spinal fluid. * The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 days, 12 to 24 weeks apart. * The follow-up period in the SAD study will be up to 52 weeks. The follow-up period in the MAD study will be up to 52 weeks post Dose 2.

Official title: A Randomized, Double-blind (Sponsor-unblinded), Placebo-controlled, Single-ascending-dose Study in Healthy Volunteers and a Double-blind (Sponsor-unblinded), Placebo-controlled, Multiple-ascending-dose Study in Patients With Parkinson's Disease to Evaluate the Safety, Tolerability, and PK/PD of LY3962681

Key Details

Gender

All

Age Range

30 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2024-08-27

Completion Date

2029-05-05

Last Updated

2026-01-14

Healthy Volunteers

Yes

Interventions

DRUG

LY3962681

IT injection

OTHER

Placebo (aCSF)

IT injection

Locations (4)

Austin Clinic PPD

Austin, Texas, United States

Ehime University Hospital

Tōon, Ehime, Japan

Oita University Hospital

Yufu, Oita Prefecture, Japan

P-One Clinic, Keikokai Medical Corporation

Hachiōji, Tokyo, Japan