This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
36
A total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen
Pulmonary Associates
Phoenix, Arizona, United States
concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF)
Time frame: Day 3
concentrations of cefepime (FEP) and zidebactam in alveolar macrophage (AM)
Time frame: Day 3
Number of adverse event reported
Time frame: Day 3
number variation noted in 12-lead electrocardiogram
Time frame: Day 3
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