FZ002 for Clostridium Difficile Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-75 who are not pregnant, have stable health, and agree to avoid probiotics and fermented foods before and during the study. Participants must use contraception if of childbearing potential and be willing to provide blood and stool samples.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- FZ002
Trial Overview
The study tests FZ002, an oral yeast modified to target C. difficile toxins, versus a placebo. It's a first-in-human safety trial where participants take capsules daily for up to 28 days in different dose groups. The main goal is to check safety and tolerability.
How Is the Trial Designed?
8
Treatment groups
Experimental Treatment
Placebo Group
Healthy adults administered with 4 capsules of FZ002 orally Q12H for 28 days. N=12
Healthy adults administered 2 capsules of FZ002 orally Q12H for 28 days. N=12
Healthy adults administered 1 capsule of FZ002 orally Q12H for 28 days. N=12
Healthy adults administered 1 capsule of FZ002 orally once daily for 28 days. N=12
Healthy adults administered 1 capsule of placebo orally once daily for 28 days. N=2
Healthy adults administered 1 capsule of placebo orally Q12H for 28 days. N=2
Healthy adults administered 2 capsules of placebo orally Q12H for 28 days. N=2
Healthy adults administered with 4 capsules of placebo orally Q12H for 28 days. N=2
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Fzata, Inc
Collaborator
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