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Tests treatment safety and results for Soil-Transmitted Helminthiasis (STH)
Official title 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)
ClinicalTrials.gov ID: NCT06128447
What this study is testing
What is ZP5-9676 600 mg dose?
ZP5-9676 600 mg dose is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for soil-transmitted helminthiasis (sth).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 59
You may be able to join if
- Provide a signed informed consent form from the participant or parent/guardian, and assent by participant(as applicable per local requirements) and...
- 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...
- Otherwise healthy based on medical history, physical examination, vital signs, and concomitant medications for inclusion.
You likely can't join 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...
- 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.
See the full eligibility criteria
- 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...
- Otherwise healthy based on medical history, physical examination, vital signs, and concomitant medications for inclusion.
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Americaninha, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 59 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Americaninha, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.