Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo- Controlled Study to Evalua… (NCT06128447) | Clinical Trial Compass
RecruitingPhase 3
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)
Brazil300 participantsStarted 2025-02-14
Plain-language 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.
Who can participate
Age range6 Months – 59 Years
SexALL
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Inclusion criteria
✓. Provide a signed informed consent form from the participant or parent/guardian, and assent by participant(as applicable per local requirements) and understand and agree to comply with required procedures in the study.
✓. Male or female, who are 6 months to 59 years old, inclusive, and live in a high STH prevalence area
✓. Positive for hookworm (A. duodenale or N. americanus), A. lumbricoides, and/or T. trichiura on microscopic examination of fecal samples.
✓. Females of childbearing potential must use an acceptable method of contraception as determined by the Investigator from the initial Screening visit through 35 days after study drug administration. A female is considered to be of childbearing potential from menarche until after menopause (age \>45 years with no menses for 12 months without an alternative medical cause) unless permanently sterile. Acceptable methods include abstinence, hormonal contraceptives, intrauterine device/system, vasectomy in the sole male sexual partner, tubal ligation, or double-barrier contraceptive method (male condom with female cervical cap, diaphragm, or sponge) with spermicide.
✓. Otherwise healthy based on medical history, physical examination, vital signs, and concomitant medications for inclusion.
Exclusion criteria
✕. Severe anemia (hemoglobin\< 8 g/dL1).
✕. Active diarrhea (passage of ≥3 loose or liquid stools per day).
✕. Children (6 months to 17 years old) with significant wasting (moderate and severe-below minus two standard deviations from median weight for height of reference population).