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More info
You can access this
clinical trial
if you have
Infections, Pseudomonas
and you are
between 20 and 55
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: Colistimethate sodium
  • Drug: Saline

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01449838. The sponsor of the trial is GlaxoSmithKline and it is looking for 22 volunteers for the current phase.
Official trial 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 -