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)

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат ZP5-9676 600 mg dose
  oral, chewable tablet formulation of flubendazole
• Препарат Placebo
  Matching placebo

Первичные конечные точки

• Cure rates [Срок оценки: 14 days]

Вторичные конечные точки (2)

• Egg reduction [Срок оценки: 14 days]
• Cure rates [Срок оценки: 14 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Clínica de Vacinas — Americaninha

Идентификаторы

NCT: NCT06128447 · ZP5-9676-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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