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 Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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:
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Treatment A: ZP5-9676 600 mg dose
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Treatment B: Placebo
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Treatment A ZP5-9676 600 mg dose |
Drug: ZP5-9676 600 mg dose
oral, chewable tablet formulation of flubendazole
|
| Placebo Comparator: Treatment B Placebo |
Drug: Placebo
Matching placebo
|
Outcome Measures
Primary Outcome Measures
- Cure rates [14 days]
Cure rates (CRs) for each STH
Secondary Outcome Measures
- Egg reduction [14 days]
Egg reduction rates (ERRs) for hookworm
- Cure rates [14 days]
Cure rates of hookworm
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Male or female, who are 6 months to 59 years old, inclusive, and live in a high STH prevalence area
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Positive for hookworm (A. duodenale or N. americanus), A. lumbricoides, and/or T. trichiura on microscopic examination of fecal samples.
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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.
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Otherwise healthy based on medical history, physical examination, vital signs, and concomitant medications for inclusion.
Exclusion Criteria:
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Severe anemia (hemoglobin< 8 g/dL1).
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Active diarrhea (passage of ≥3 loose or liquid stools per day).
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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).
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Women who are pregnant.
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Hypersensitivity or allergy to ZP5-9676 or any inert ingredients in the chewable formulation or other medications in the benzimidazole class.
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Taken ZP5-9676 or any other treatment for STH infection within 30 days of screening or randomization.
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Used an investigational medical device within 30 days of screening.
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Preplanned surgery procedures within 30 days of screening.
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History of a medical disorder causing difficulty in chewing or swallowing.
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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).
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Participation in an interventional clinical study within 30 days of screening.
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Any condition that interferes with the ability to understand or comply with the requirements of the study.
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Any other medical condition, serious illness, or other circumstance that would place the subject at increased risk, as determined by the Investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clínica de Vacinas | Americaninhas | Brazil | ||
| 2 | Noguchi Memorial Institute for Medical Research | Accra | Ghana |
Sponsors and Collaborators
- Zero Point Five Therapeutics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZP5-9676-301