The randomized, double-blind, placebo-controlled Phase Ib trial is currently underway at Clinical Pharmacology of Miami.
It is designed to further evaluate the safety, tolerability and pharmacokinetics of multiple-ascending doses of oral SYN-004 in healthy volunteers.
A total of 24 healthy adult volunteers will be enrolled into three groups, with six participants receiving SYN-004 and two participants receiving placebo in each group.
In the Phase Ib clinical trial, six volunteers per group will receive increasing doses of SYN-004 by cohort, four times a day over a seven-day period.
Synthetic Biologics chief executive officer Jeffrey Riley said: "I’m pleased Synthetic Biologics continues to hit its milestones as outlined earlier this year and look forward to a productive 2015.
"Moving Synthetic Biologics’ innovative, point-of-care therapeutic approach to prevent C. difficile infection through clinical development is high priority for the Company.
"We look forward to reporting topline data from the Phase Ib clinical trial and initiating enrollment in a Phase II SYN-004 clinical trial during the first quarter of 2015."
SYN-004 is designed to be the first and only treatment intended to prevent C. difficile infection and its mechanism of action is to bind with as well as neutralize certain common IV beta-lactam antibiotics in the gut.