NCT06822517

A Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease

A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Ventus Therapeutics U.S., Inc. · Industry
• Sex: All
• Age: 45 Years – 90 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	VENT-02	Orally administered capsules
DRUG	Placebo	Orally administered capsules

Timeline

• Start date: 2025-03-05
• Primary completion: 2025-10-09
• Completion: 2025-10-09
• First posted: 2025-02-12
• Last updated: 2025-10-29

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study