Healthy Clinical Trial
Official title:
A Phase I Study to Determine and Compare Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous ETX2514 and Sulbactam Administered to Healthy Adult Subjects
This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult male and female subjects to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of ETX2514 and sulbactam in healthy adult subjects after intravenous infusion of ETX2514 1.0 g given concurrently with intravenous sulbactam 1.0 g, administered every 6 hours with each infused over 3 hours, for 3 consecutive doses
Blood samples for determining plasma concentrations of ETX2514 and sulbactam will be
collected within 5 minutes prior to and at 1.0, 2.0, 2.5, 2.95, 3.05, 3.25, 3.5, 4.0, 5.0 and
6.0 hours after start of the third dose (last dose) administered on Day 2.
Each subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in
the outpatient bronchoscopy suite at 1.0, 2.5, 3.25, 4.0, or 6.0 hours after start of the
infusion of the third dose of ETX2514 and sulbactam (6 subjects per timepoint) on Day 2.
Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory
tests, ECG, physical examination, and vital sign monitoring.
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