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.
Provides written informed consent prior to the initiation of any trial procedures.
Receiving 28 days of blinded oral study product
Providing blood and self-collected stool samples
Is a non-pregnant individual, aged 18-75 years, inclusive, at the time of enrollment.
Dwells in a long-term care or skilled nursing facility (living independently with limited nursing care is allowable).
Known to be pregnant or has a positive pregnancy test at screening or enrollment.
Currently breastfeeding a child.
Known to have significant hypersensitivity to any components of the study product; including S. boulardii (or any S. boulardii-based nutritional supplement), hydroxypropyl methylcellulose, and Microcrystalline cellulose [MCC].
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Treatment groupsSee each treatment group below.
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Fzata, Inc
Collaborator