The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an antibacterial compound for treatment of hospital acquired Gram negative infection.
Single-center, randomized, placebo-controlled, double-blind study to determine the safety, tolerability and pharmacokinetic profile of compound in single and multiple doses in young healthy males.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
CMAX
Adelaide, Australia
Clinical safety data from 12-lead ECG, clinical laboratory tests, urinalysis, injection site tolerability, spontaneous/elicited adverse event reporting, and vital signs (blood pressure, heart rate, respiratory rate)
Time frame: Multiple time points up to 14 days
Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality
Time frame: Multiple time points up to 14 days
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