Novo Oriente De Minas

Researchers are evaluating the effectiveness, safety, and tolerability of ZP5-9676, a chewable oral tablet formulation of flubendazole, for treating Soil-Transmitted Helminthiasis (STH). This Phase 3, multi-center, prospective, randomized, double-blind, placebo-controlled study aims to compare ZP5-9676 to a matching placebo in approximately 300 infected participants, including both children and adults aged 6 months to 59 years living in high STH prevalence areas. The study focuses on infections caused by hookworm (Ancylostoma duodenale and Necator americanus), Ascaris lumbricoides, and Trichuris trichiura. Participants will be randomly assigned in a 1:1 ratio to receive either the active treatment ZP5-9676 at a 600 mg dose or a placebo. After this initial treatment, participants will receive standard of care treatment. The study timeline includes a Baseline visit on Day 1 when randomization occurs, followed by treatment administration and monitoring. During the study, participants will undergo microscopic examination of fecal samples to confirm infection and will be assessed for cure rates at 14 days after treatment. Researchers will monitor participant health through medical history, physical examination, vital signs, and medication review to ensure safety and tolerability. Female participants of childbearing potential will use contraception from screening through 35 days post-treatment. The total participation duration spans from screening through the Test of Cure visit at Day 14.