Infections, Pseudomonas Clinical Trial
Official title:
Phase I Study of Colistin Methanesulfonate Sodium (CMS-Na) -A Randomized, Double Blind, Placebo Controlled, Single and Repeat Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of CMS-Na in Healthy Japanese Male Subjects -
This is a clinical study protocol for a single centre, randomized, double blind, placebo
controlled, single and repeat dose study to investigate the safety, tolerability and
pharmacokinetics of intravenous dosing of Colistin Methanesulfonate Sodium (CMS-Na) in
healthy Japanese male subjects.
Eighteen subjects will receive CMS-Na 2.5mg/kg (as colistin activity or 75,000 IU/kg) or
placebo as a single dose and twice daily for 2.5 days by intravenous infusion.
Blood and urine samples for pharmacokinetics analysis will be taken at regular intervals
after dosing. Safety will be assessed by measurement of vital signs, Echocardiogram (ECGs),
safety laboratory data, renal function and review of adverse events.
n/a