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

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.

NCT Number	NCT07649096
Lead Sponsor	National Institute of Allergy and Infectious Diseases (NIAID) Collaborators: Fzata, Inc
Conditions	Clostridium Difficile Infection
Enrollment	86 participants
Start Date	2026-07-27
Primary Completion	2028-08-22 (estimated)
Study Completion	2028-09-22 (estimated)
Updated on ClinicalTrials.gov	2026-08-14