drugset / Trial / NCT06128447

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)

NCT06128447 ↗

Phase 3 Recruiting 300 enrolled Zero Point Five Therapeutics
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-02-14
Primary completion
2026-05-01
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator flubendazole Small molecule 600 mg Oral