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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
29
Investigative Site
Fountain Valley, California, United States
Incidence of treatment-emergent adverse events (TEAEs)
Number of treatment-emergent adverse events (TEAEs) with VENT-02 treatment compared to placebo
Time frame: Baseline to Follow-up Visit (Day 35)
Concentrations of biomarkers
Change from baseline in concentrations of biomarkers of inflammation and neurodegeneration in plasma and CSF
Time frame: Baseline to Day 28
Concentrations of VENT-02 in plasma and CSF
PK as measured by concentrations of VENT-02 in plasma and CSF
Time frame: Baseline to Day 28
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Investigative Site
San Jose, California, United States
Investigative Site
West Hills, California, United States
Investigative Site
Englewood, Colorado, United States
Investigative Site
Aventura, Florida, United States
Investigative Site
Boca Raton, Florida, United States
Investigative Site
Coral Gables, Florida, United States
Investigative Site
Coral Springs, Florida, United States
Investigative Site
Cutler Bay, Florida, United States
Investigative Site
Daytona Beach, Florida, United States
...and 13 more locations