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 studyparticipants, will be randomly allocated to receive either FZ002 or placebo. Part A isdesigned 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 beevaluated in the study. In the event of a safety or tolerability concern in Cohort 1, adose de‐escalation will be evaluated in Cohorts 2‐4 until a safe and well‐tolerated doseis identified. If no safety or tolerability concerns are identified at the completion ofa cohort, the study will proceed to Part B with the approval of the independent SafetyMonitoring Committee (SMC). This adaptive design allows for the progression of the studyfrom Part A to Part B without necessarily progressing through all 4 cohorts in Part A ifthere is a lack of safety or tolerability concerns.During Part B, an initial 'sentinel' Cohort 5 "some‐risk" adult study participants willbe randomly allocated to receive a single daily dose of FZ002 or placebo for 28consecutive days. This is intended to represent the "floor" (lowest level) of doses to beevaluated in the study. A Protocol Safety Review Team (PSRT) will review the availablesafety data from the first 7 days of Cohort 5. If there is a lack of safety ortolerability concerns over the first 7‐days of dosing for Cohort 5, then Cohort 6 will beopened 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 ofFZ002 or placebo when taken for up to 28 days. The secondary objective is to evaluatelaboratory abnormalities with FZ002 or placebo when taken for up to 28 days.