Phase 3 Randomized Study of ZP5-9676 Chewable Tablets to Treat Soil-Transmitted Helminth Infections Including Hookworm, Ascaris, and Trichuris in Children and Adults

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and tolerability of ZP5-9676 compared to a placebo for treating soil-transmitted helminth infections. This Phase 3, multi-center, prospective, randomized, double-blind, placebo-controlled study aims to enroll about 300 participants who have infections like hookworm, Ascaris lumbricoides, or Trichuris trichiura. The study intends to ensure at least 114 participants infected with hookworm complete the test of cure visit on Day 14. Participants will be randomly assigned in equal numbers to receive either a 600 mg dose of ZP5-9676, an oral chewable tablet formulation of flubendazole, or a matching placebo. After the treatment, participants will receive standard care. The study compares the active drug against placebo to assess cure rates and egg reduction at 14 days post-treatment. During the study, participants will be monitored for cure rates and reduction in parasite eggs through microscopic examination of fecal samples, especially at Day 14. Researchers will also assess safety and tolerability. The total participation includes screening, treatment, and follow-up visits to evaluate the study outcomes and ensure participant well-being throughout the trial.

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)