A Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease
NCT06822517 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2025-10-29
Summary
This trial is a randomized, double-blind, placebo-controlled Phase 1b study evaluating the safety/tolerability, PK, and pharmacodynamics of VENT 02, administered orally at 1 dose level twice daily (BID) over 28 days in patients with mild to moderate Parkinson's disease.
The study includes a screening period, a 28-day double-blind treatment period, and a 7-day follow-up period after last dose.
Approximately 30 patients will be randomized into 1 of the 2 treatment arms.
Conditions
- Parkinson Disease
Interventions
- DRUG
-
VENT-02
Orally administered capsules
- DRUG
-
Orally administered capsules
Sponsors & Collaborators
-
Ventus Therapeutics U.S., Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-05
- Primary Completion
- 2025-10-09
- Completion
- 2025-10-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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