ZP5-9676 (600 mg) versus placebo for treating soil-transmitted worm infections

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

This study tests whether a single 600 mg dose of ZP5-9676 works better than a placebo to cure soil-transmitted worm infections in people aged 6 months to 59 years who live in high-prevalence areas.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 6 Months to 59 Years
• Sex: All
• Sponsor: Zero Point Five Therapeutics (Industry-sponsored)
• Locations: 1 site (Americaninha)
• Trial ID: NCT06128447 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, double-blind, placebo-controlled trial will enroll about 300 participants with microscopy-confirmed soil-transmitted helminth infections and randomize them 1:1 to a single 600 mg dose of ZP5-9676 or placebo. Participants will be followed with a Test of Cure visit at Day 14 with special attention to ensuring a minimum number of evaluable hookworm-infected participants. Some participants with co-infections may be counted for multiple species analyses. After the investigational dosing and study evaluations, participants will receive standard-of-care treatment.

Who should consider this trial

Good fit: Ideal candidates are males or females aged 6 months to 59 years who live in high STH prevalence areas and have microscopy-confirmed infection with hookworm, Ascaris lumbricoides, and/or Trichuris trichiura.

Not a fit: People without confirmed STH infection, those outside the 6 months–59 years age range, and pregnant women or others with medical contraindications are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, ZP5-9676 could provide a single-dose, more effective oral treatment for common intestinal worm infections, improving cure rates and simplifying mass treatment efforts.

How similar studies have performed: Single-dose oral anthelmintics have shown mixed success—licensed drugs are effective against some STH species but efficacy varies, so ZP5-9676 is a relatively novel candidate now being tested in Phase 3.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Male or female, who are 6 months to 59 years old, inclusive, and live in a high STH prevalence area
3. Positive for hookworm (A. duodenale or N. americanus), A. lumbricoides, and/or T. trichiura on microscopic examination of fecal samples.
4. 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.
5. Otherwise healthy based on medical history, physical examination, vital signs, and concomitant medications for inclusion.

Exclusion Criteria:

1. Severe anemia (hemoglobin\< 8 g/dL1).
2. Active diarrhea (passage of ≥3 loose or liquid stools per day).
3. 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).
4. Women who are pregnant.
5. Hypersensitivity or allergy to ZP5-9676 or any inert ingredients in the chewable formulation or other medications in the benzimidazole class.
6. Taken ZP5-9676 or any other treatment for STH infection within 30 days of screening or randomization.
7. Used an investigational medical device within 30 days of screening.
8. Preplanned surgery procedures within 30 days of screening.
9. History of a medical disorder causing difficulty in chewing or swallowing.
10. 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).
11. Participation in an interventional clinical study within 30 days of screening.
12. Any condition that interferes with the ability to understand or comply with the requirements of the study.
13. Any other medical condition, serious illness, or other circumstance that would place the subject at increased risk, as determined by the Investigator

Where this trial is running

Americaninha

• Clínica de Vacinas — Americaninha, Brazil (Recruiting)

Study contacts

• Study coordinator: Helen Pentikis

Conditions Soil-Transmitted Helminthiasis