Phase Ib study on prevention of C. difficilis infections

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Synthetic Biologics , a biotech company, is working on a phase Ib clinical trial of SYN-004, a beta-lactamase proposal for the prevention of infection by Clostridium difficilis (C. difficilis). The randomized, double-blind, placebo-controlled phase Ib is underway in Miami and has been designed to further assess the safety, tolerability and pharmacokinetics of multiple oral doses and increasing of SYN-004 in healthy volunteers. A total of 24 healthy adult volunteers will be enrolled into three groups, with six participants who will receive SYN-004 and two participants treated with placebo for each group. In the clinical trial Phase Ib, six volunteers per group receive increasing doses of SYN-004 per cohort, four times a day for a period of seven days. SYN-004 is designed to be the first and only treatment to prevent infection with C. difficilis.

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