LB7. A Randomized Blinded Placebo- and Vancomycin-Controlled First-In-Human (FIH) Study of the Safety Pharmacokinetics (PK) and Fecal Microbiome Effects of ACX-362E a Novel Anti-Clostridial DNA Polymerase IIIC (polIIIC) Inhibitor

摘要

BackgroundACX-362E, a novel DNA polIIIC inhibitor, is a narrow-spectrum antibacterial selectively active against certain Gram-positive bacteria, including Clostridioides difficile (MIC90 = 4 µg/mL). The objectives of this phase I study was to assess the safety, pharmacokinetics, and fecal microbiome effects of ACX-362E