Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose and Multiple-ascending-dose Study of LY3962681 Injected into the Spinal Fluid in Healthy Volunteers and Parkinson's Disease Patients to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics
Led by Prevail Therapeutics · Updated on 2026-05-18
124
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and behavior in the body (pharmacokinetics/pharmacodynamics) of a drug called LY3962681 in both healthy volunteers and patients with Parkinson's disease. This study is divided into two parts: the Single Ascending Dose (SAD) study involving healthy participants and the Multiple Ascending Dose (MAD) study involving Parkinson's patients. The study aims to understand how the drug works and how safe it is when given in different doses. In the SAD part, healthy volunteers will receive one dose of LY3962681 or a placebo injected into the spinal fluid. In the MAD part, Parkinson's patients will receive two doses of the drug or placebo, also injected into the spinal fluid, spaced 12 to 24 weeks apart. The SAD treatment lasts one day, while the MAD treatment includes two dosing days separated by a few months. Participants will be monitored for up to 52 weeks after their final dose. During this time, researchers will watch for any serious or new side effects, track how the drug moves and acts in the body, and measure changes in specific Parkinson's disease markers in spinal fluid. The study involves medical evaluations, cognitive tests, and safety monitoring throughout the follow-up period to ensure participant well-being.
CONDITIONS
Brief Title
A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is overtly healthy as determined by medical evaluation (rescreening allowed).
- Montreal Cognitive Assessment score of 24 or higher.
- Stable use of background medications for at least 8 weeks before study drug administration.
- For MAD study only: diagnosis of Parkinson's disease by UK Brain Bank criteria.
- For MAD study only: Modified Hoehn and Yahr Stage 1 to 2.5 in OFF state.
- For MAD study only: positive CSF alpha-synuclein Seed Amplification Assay or prior approved positive result.
- For MAD study only: UPSIT score at 20th percentile or less (EU and UK only).
- For MAD study only: abnormal DaT-SPECT consistent with parkinsonism.
- For MAD study only: no planned initiation of Parkinson's disease medications within 6 months if not currently treated.
- Body weight between 40 kg and 110 kg inclusive, and BMI between 17 and 34 kg/m² inclusive.
You will not qualify if you...
- For MAD study only: significant neurological disease other than Parkinson's disease affecting the central nervous system.
- Current serious or unstable illnesses including central nervous system diseases (SAD study only), cardiovascular, hepatic, renal, gastroenterology, respiratory, endocrinologic, neurologic (other than Parkinson's, MAD only), psychiatric, immunologic, or hematologic diseases.
- General frailty or medical disorders that interfere with study procedures such as spinal disease, bleeding disorders, coagulopathy, thrombocytopenia, or increased intracranial pressure.
- Abnormal 12-lead ECG at screening increasing risks or confounding analysis.
- For MAD study only: treatment with continuous intestinal delivery Parkinson's medication (e.g., Duodopa).
- For MAD study only: significant renal impairment (eGFR below 45 mL/min/1.73 m²).
- Other protocol-defined criteria may apply.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 76 weeks
Participants receive single or multiple ascending doses of LY3962681 or placebo injected into the spinal fluid to evaluate safety and pharmacokinetics.
Multiple visits for dosing and assessments during treatment period
Trial Site Locations
Total: 4 locations
1
Austin Clinic PPD
Austin, Texas, United States, 78744-1625
Actively Recruiting
2
Ehime University Hospital
Tōon, Ehime, Japan, 791-0295
Not Yet Recruiting
3
Oita University Hospital
Yufu, Oita Prefecture, Japan, 879-5593
Not Yet Recruiting
4
P-One Clinic, Keikokai Medical Corporation
Hachiōji, Tokyo, Japan, 192-0071
Actively Recruiting
Research Team
P
Prevail Therapeutics
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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