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.
Approximately 300 infected participants will be enrolled to ensure that there is a minimum of 114 hookworm-infected participants evaluable for the Test of Cure study visit (Day 14). Some participants may be co-infected and will be included in each tally. Participants will be randomized (1:1) to one of the treatments below followed by standard of care treatment: * Treatment A: ZP5-9676 600 mg dose * Treatment B: Placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
oral, chewable tablet formulation of flubendazole
Matching placebo
Clínica de Vacinas
Americaninha, Brazil
RECRUITINGCure rates
Cure rates (CRs) for each STH
Time frame: 14 days
Egg reduction
Egg reduction rates (ERRs) for hookworm
Time frame: 14 days
Cure rates
Cure rates of hookworm
Time frame: 14 days
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