NCT06128447招募中3 期
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
Zero Point Five Therapeutics1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年2月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Cure rates
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Treatment B
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Treatment A
Active Comparator
ZP5-9676 600 mg dose
干预措施: ZP5-9676 600 mg dose (Drug)
结局指标
主要结局
Cure rates
时间窗: 14 days
Cure rates (CRs) for each STH
次要结局
- Egg reduction(14 days)
- Cure rates(14 days)
研究者
研究点 (1)
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