Soil-Transmitted Helminthiasis (STH)Phase 3NCT06128447
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)
A Phase 3 study testing ZP5-9676 600 mg dose in people with Soil-Transmitted Helminthiasis (STH), run by Zero Point Five Therapeutics at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 59 years
- Conditions the study is for
- Soil-Transmitted Helminthiasis (STH)
- What is being tested?
- ZP5-9676 600 mg dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Feb 2025to 31 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Clínica de Vacinas
Americaninha
Ana Carolina Bernardes Terzian, DVM, MSc, PhD
About this study
Official title: 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 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.
Read the 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)
- Being tested
- ZP5-9676 600 mg dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZP5-9676 600 mg doseDrug
oral, chewable tablet formulation of flubendazole
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | ZP5-9676 600 mg dose Receives: Drug: ZP5-9676 600 mg dose |
| Treatment B | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rates
Cure rates (CRs) for each STH
Measured: 14 days
Secondary outcomes (2)
Egg reduction
Egg reduction rates (ERRs) for hookworm
Measured: 14 days
Cure rates
Cure rates of hookworm
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start14 Feb 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soil-Transmitted Helminthiasis (STH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, double-blind, placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zero Point Five Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128447
- Sponsor's protocol ID
- ZP5-9676-301
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06128447
- Acronym / sponsor ID
- ZP5-9676-301
- Conditions
- Soil-Transmitted Helminthiasis (STH)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zero Point Five TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- prospective, randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: ZP5-9676 600 mg doseZP5-9676 600 mg dose |
| Treatment B | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 6 months to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZP5-9676 600 mg doseoral, chewable tablet formulation of flubendazole | Drug | Treatment A |
| PlaceboMatching placebo | Drug | Treatment B |
Primary outcome
Cure rates
Time frame: 14 days
Cure rates (CRs) for each STH
2 secondary outcomes
Egg reduction
Time frame: 14 days
Cure rates
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZP5-9676 600 mg dose in people with Soil-Transmitted Helminthiasis (STH), run by Zero Point Five Therapeutics at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Pentikis (4103364031, hpentikis@zeropointfivetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rates (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.