New Worm-Fighting pill could help millions of children
NCT ID NCT06128447
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This phase 3 trial tests a chewable tablet called ZP5-9676 (flubendazole) against common intestinal worms like hookworm, roundworm, and whipworm. About 300 people aged 6 months to 59 years from high-risk areas will receive either the drug or a placebo. The goal is to see if the drug can cure the infection and reduce egg counts in stool.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ZP5-9676 (flubendazole) chewable tablet
- What this could lead to
- If successful, this could provide a new, effective treatment for common intestinal worm infections, improving health in affected communities.
- What could go wrong
- This is a placebo-controlled trial, so some participants may not receive active treatment. Results may vary by worm type, and long-term effectiveness is not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months to 59 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clínica de Vacinas
RECRUITINGAmericaninha, Brazil