MedTrace Logo

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

NCT07649096 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-08-14

No results posted yet for this study

Summary

This is a Phase 1, first-in-human, double-blind, placebo-controlled, adaptive-design, single-site study, involving dose exploration cohorts.

During Part A, up to 4 cohorts, each consisting of approximately 14 healthy adult study participants, will be randomly allocated to receive either FZ002 or placebo. Part A is designed to begin with Cohort 1 evaluating the highest proposed dose of study product. This is intended to represent the "ceiling" (highest level) of the ranges of doses to be evaluated in the study. In the event of a safety or tolerability concern in Cohort 1, a dose de-escalation will be evaluated in Cohorts 2-4 until a safe and well-tolerated dose is identified. If no safety or tolerability concerns are identified at the completion of a cohort, the study will proceed to Part B with the approval of the independent Safety Monitoring Committee (SMC). This adaptive design allows for the progression of the study from Part A to Part B without necessarily progressing through all 4 cohorts in Part A if there is a lack of safety or tolerability concerns.

During Part B, an initial 'sentinel' Cohort 5 "some-risk" adult study participants will be randomly allocated to receive a single daily dose of FZ002 or placebo for 28 consecutive days. This is intended to represent the "floor" (lowest level) of doses to be evaluated in the study. A Protocol Safety Review Team (PSRT) will review the available safety data from the first 7 days of Cohort 5. If there is a lack of safety or tolerability concerns over the first 7-days of dosing for Cohort 5, then Cohort 6 will be opened for enrollment. Cohort 6 "some-risk" adult study participants will evaluate the "floor" and "ceiling" dose of FZ002 versus 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.

Conditions

  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

FZ002

A recombinant live biotherapeutic product (rLBP) for oral administration, bioengineered from the parental S. boulardii (Sb) strain to constitutively produce ABAB, an anti-toxin against TcdA and TcdB of CDiff, intended to reduce the risk of CDI recurrence.

OTHER

Placebo for FZ002

The placebo is a capsule filled with commercially sourced pharmaceutical-grade microcrystalline cellulose (MCC), an inert substance. No anticipated risk related to the study product.

Sponsors & Collaborators

  • Fzata, Inc

    collaborator UNKNOWN

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-27
Primary Completion
2028-08-22
Completion
2028-09-22
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07649096 on ClinicalTrials.gov