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)

NCT ID: NCT06128447

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2026-12-31

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.

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 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

Conditions

Soil-Transmitted Helminthiasis (STH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment A

ZP5-9676 600 mg dose

Group Type: ACTIVE_COMPARATOR

ZP5-9676 600 mg dose

Intervention Type: DRUG

oral, chewable tablet formulation of flubendazole

Treatment B

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo

Interventions

ZP5-9676 600 mg dose

oral, chewable tablet formulation of flubendazole

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zero Point Five Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clínica de Vacinas

Americaninha, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Helen Pentikis

Role: CONTACT

hpentikis@zeropointfivetherapeutics.com

4103364031

Facility Contacts

Ana Carolina Bernardes Terzian, DVM, MSc, PhD

Role: primary

Other Identifiers

ZP5-9676-301

Identifier Type: -

Identifier Source: org_study_id