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Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Effectiveness and Safety of ZP5-9676 for the Treatment of Soil Transmitted Helminthiasis (STH)
Sponsor: Zero Point Five Therapeutics
Summary
This is a Phase 3, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectiveness, safety, and tolerability of ZP5-9676 compared to placebo for the treatment of STH infections. Approximately 300 participants will be enrolled, randomized at the Baseline visit (Day 1) to one of the following treatments in a 1:1 ratio of active and placebo.
Official title: A Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Effectiveness and Safety of ZP5-9676 for the Treatment of Hookworm (Ancylostoma Duodenale and Necator Americanus), Ascaris Lumbricoides, and Trichuris Trichiura in Pediatric and Adult Participants
Key Details
Gender
All
Age Range
6 Months - 59 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-02-14
Completion Date
2026-12-31
Last Updated
2025-09-25
Healthy Volunteers
No
Conditions
Interventions
ZP5-9676 600 mg dose
oral, chewable tablet formulation of flubendazole
Placebo
Matching placebo
Locations (1)
Clínica de Vacinas
Americaninha, Brazil