Actively Recruiting
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)
Led by Zero Point Five Therapeutics · Updated on 2025-09-25
300
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed informed consent (and assent if applicable) and agree to study procedures
- Male or female aged 6 months to 59 years inclusive
- Live in a high Soil-Transmitted Helminthiasis (STH) prevalence area
- Positive for hookworm, Ascaris lumbricoides, and/or Trichuris trichiura by fecal microscopic exam
- Females of childbearing potential must use acceptable contraception from screening through 35 days post-treatment
- Otherwise healthy based on medical history, physical exam, vital signs, and medication use
You will not qualify if you...
- Severe anemia (hemoglobin less than 8 g/dL)
- Active diarrhea with 3 or more loose or liquid stools per day
- Children 6 months to 17 years old with moderate or severe wasting (weight for height below minus two standard deviations)
- Pregnant women
- Allergy or hypersensitivity to ZP5-9676, its ingredients, or benzimidazole drugs
- Received ZP5-9676 or other STH treatments within 30 days before screening or randomization
- Used an investigational medical device within 30 days before screening
- Planned surgery within 30 days before screening
- Medical history causing difficulty chewing or swallowing
- Participated in investigational drug trials within 30 days or six half-lives of the test drug
- Participated in interventional clinical studies within 30 days before screening
- Any condition interfering with understanding or complying with study requirements
- Other serious medical conditions or risks as determined by the Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clínica de Vacinas
Americaninha, Brazil
Actively Recruiting
Research Team
H
Helen Pentikis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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