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.
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 a yeast allergy or 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].
Sequential
FZ002
Biological/VaccineA 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.
Placebo for FZ002
Other interventionThe placebo is a capsule filled with commercially sourced pharmaceutical-grade microcrystalline cellulose (MCC), an inert substance. No anticipated risk related to the study product.
8
Treatment groupsSee each treatment group below.
Occurrence of serious adverse events (SAEs)
Occurrence of solicited adverse events (AEs)
Solicited AEs will include headache, fever, nausea, abdominal pain, diarrhea, malaise, constipation, fatigue, and vomiting. Oral temperatures will be measured daily.
Occurrence of unsolicited AEs
The occurrence of any positive yeast blood culture for Saccharomyces
The occurrence of safety laboratory adverse events
laboratory parameters include White blood cell \[WBC\], Absolute neutrophil count \[ANC\], Hemoglobin \[Hg\], Platelets \[PLT\], creatinine, Alanine aminotransferase \[ALT\], Aspartate aminotransferase \[AST\], and total bilirubin
Click on the lead sponsor to view all of their trials.
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Fzata, Inc
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
