RecruitingPhase 1NCT06565195

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

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


Sponsor

Prevail Therapeutics

Enrollment

108 participants

Start Date

Aug 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 30 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug (LY3962681) to evaluate its safety and how it behaves in the body — first in healthy volunteers, and then in patients with Parkinson's disease. The goal is to establish a safe dose and understand how the drug interacts with disease-related biomarkers. **You may be eligible if...** - For healthy volunteers: you are generally healthy with no significant medical conditions - For Parkinson's patients: you have a confirmed diagnosis of Parkinson's disease with stage 1–2.5 severity (mild-to-moderate, still able to function independently) - Your cognition is intact (Montreal Cognitive Assessment score ≥24) - Your other medications have been stable for at least 8 weeks - Your body weight is between 40–110 kg (about 88–242 pounds) **You may NOT be eligible if...** - You have significant organ problems (heart, liver, kidney, or lung) - You have a history of certain cancers or active infections - You are pregnant or breastfeeding - Your Parkinson's medications are expected to change significantly in the next 6 months - You have had major surgery in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY3962681

IT injection

OTHERPlacebo (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

View Full Details on ClinicalTrials.gov

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NCT06565195


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