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RECRUITING
NCT06128447
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

ZP5-9676 600 mg dose

oral, chewable tablet formulation of flubendazole

DRUG

Placebo

Matching placebo

Locations (1)

Clínica de Vacinas

Americaninha, Brazil