National Institute of Allergy and Infectious Diseases (NIAID)
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.
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 (FZ2…
Inclusion Criteria: To be eligible to participate in this trial, an individual must meet all of the following criteria: 1. Provides written informed consent prior to the initiation of any trial procedures. 2. Is able to understand and agrees to comply with all planned trial procedures and be available for all study visits, including: 1. Receiving 28 days of blinded oral study product 2. Providing blood and self-collected stool samples 3. Is a non-pregnant individual, aged 18-75 years, inclusive, at the time of enrollment. 4. Has no more than 1 single Grade 1 screening laboratory abnor…
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.
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.
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