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)

NCT06128447 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: ZP5-9676-301
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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 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

Soil-Transmitted Helminthiasis (STH)

Outcome Measures

Primary Outcomes (1)

• Cure rates

  Cure rates (CRs) for each STH

  14 days

Secondary Outcomes (2)

• Egg reduction

  14 days

• Cure rates

  14 days

Study Arms (2)

Treatment A

ACTIVE COMPARATOR

ZP5-9676 600 mg dose

Drug: ZP5-9676 600 mg dose

Treatment B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

ZP5-9676 600 mg dose DRUG

oral, chewable tablet formulation of flubendazole

Treatment A

Placebo DRUG

Matching placebo

Treatment B

Eligibility Criteria

• Age: 6 Months - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zero Point Five Therapeutics: lead

Study Sites (1)

Clínica de Vacinas

Americaninha, Brazil

RECRUITING

Central Study Contacts

Helen Pentikis

CONTACT

4103364031; hpentikis@zeropointfivetherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: February 14, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)