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)

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Soil-Transmitted Helminthiasis (STH)

Intervention / Treatment
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* Drug: ZP5-9676 600 mg dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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). Women who are pregnant. Hypersensitivity or allergy to ZP5-9676 or any inert ingredients in the chewable formulation or other medications in the benzimidazole class. Taken ZP5-9676 or any other treatment for STH infection within 30 days of screening or randomization. Used an investigational medical device within 30 days of screening. Preplanned surgery procedures within 30 days of screening. History of a medical disorder causing difficulty in chewing or swallowing. Participation in any investigational drug (including vaccine) trial within 30 days or six half-lives of the test drug's biologic activity, whichever is longer, before the start of the study (time of first dose). Participation in an interventional clinical study within 30 days of screening. Any condition that interferes with the ability to understand or comply with the requirements of the study. Any other medical condition, serious illness, or other circumstance that would place the subject at increased risk, as determined by the Investigator

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, double-blind, placebo-controlled study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A<br>ZP5-9676 600 mg dose | Drug: ZP5-9676 600 mg dose<br>* oral, chewable tablet formulation of flubendazole<br>|
| Placebo Comparator: Treatment B<br>Placebo | Drug: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rates | Cure rates (CRs) for each STH | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Egg reduction | Egg reduction rates (ERRs) for hookworm | 14 days | 
| Cure rates | Cure rates of hookworm | 14 days |