Status:
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)
Lead Sponsor:
Zero Point Five Therapeutics
Conditions:
Soil-Transmitted Helminthiasis (STH)
Eligibility:
All Genders
6-59 years
Phase:
PHASE3
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 treatme...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06128447
Start Date
February 14 2025
End Date
December 31 2026
Last Update
September 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clínica de Vacinas
Americaninha, Brazil