A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile
Public ClinicalTrials.gov record NCT07649096. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Trial to Evaluate an Orally Ingested Probiotic Yeast Genetically Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 1, first-in-human, double-blind, placebo-controlled, adaptive-design, single-site study, involving dose exploration cohorts. During dose escalation, up to 4 cohorts, each consisting of up to 14 healthy adult (18-75 years, inclusive) study participants, will be randomly allocated to receive either FZ002 (n=12) or placebo (n=2). Dose escalation is designed to begin with the first cohort (Cohort 1) evaluating the lowest proposed dose of study product (1 capsules taken daily for 28 consecutive days). The first 3 participants will serve as sentinels and randomized in 2:1 ratio (FZ200: placebo). After review of the sentinel participants' data by the PSRT, the remaining participants (n=11) in the cohort will be randomly allocated in a 10:1 ratio (FZ002: placebo). The primary objective is to evaluate safety and clinical tolerability of oral doses of FZ002 or placebo when taken for up to 28 days.
Study identification
- NCT ID
- NCT07649096
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 56 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 29, 2026 (Estimated)
- Primary completion
- Aug 22, 2028 (Estimated)
- Completion
- Sep 22, 2028 (Estimated)
- Last update posted
- Oct 26, 2026
2026 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alliance for Multispecialty Research, LLC - Knoxville | Knoxville | Tennessee | 37920 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07649096, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 26, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07649096 live on ClinicalTrials.gov.