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A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 35% 86 → 56 participants
See other at-risk trials from National Institute of Allergy and Infectious Diseases (NIAID)

Record History

  1. Re-verified, no change to tracked fields
  2. Enrollment reduced: 86 → 56 participants Trial arms changed: 14 → 8 · Eligibility criteria shortened, about 496 words · Secondary endpoint revised · 1 more Show 4 more changesShow less
    • Trial arms changed: 14 → 8
    • Eligibility criteria shortened, about 496 words
    • Secondary endpoint revised
    • Study description shortened, about 77 words
  3. Eligibility criteria expanded, about 52 words Secondary endpoints: details revised at 1 of 1 entry Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 1 entry
  4. 2 versions Re-verified since Sep 3, 2026, no change to tracked fieldsv11-v12
  5. Start date: Jul 27, 2026 to Sep 17, 2026v10
Show 8 earlier versionsHide 8 earlier versions
  1. 5 versions Re-verified since Jul 23, 2026, no change to tracked fieldsv5-v9
  2. Start date: Jun 15, 2026 to Jul 27, 2026v4
  3. 2 versions Re-verified since Jun 18, 2026, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07649096
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Fzata, Inc
Conditions Clostridium Difficile Infection
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov