Urinary Tract Infection Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, Randomized, Dose-Escalating Study of Single and Multiple Oral Doses of Finafloxacin Hydrochloride in Healthy Subjects and a Study of H. Pylori Treatment in Healthy Carriers
The purpose of this study is to study the safety of single doses and multiple doses of Finafloxacin hydrochloride in healthy volunteers. The level of Finafloxacin hydrochloride will be measured in the subjects blood and urine. One part of the study will assess if Finafloxacin hydrochloride eradicates Helicobacter pylori, a stomach bacteria. Another part of the study will assess the activity of the drug in urine.
New antibiotics are needed due to the increasing resistance of bacteria to existing
antibiotics. Helicobacter pylori (H. pylori) is a bacteria of the stomach and has been shown
to cause peptic ulcers and is implicated in gastric cancer. Up to 40% of the population has
H. pylori. Current treatments used to eradicate H. pylori are a combination of a number of
drugs including antibiotics and drugs which reduce the acid in the stomach. These treatments
are complicated and some H. pylori is resistant to the antibiotics used.
This study is the first use of Finafloxacin hydrochloride in man and will examine its safety
and make a preliminary study of its effectiveness as a single agent in eradicating H.
pylori. The urine of subjects will also be used to test its effectiveness in killing the
bacteria which cause urinary tract infections.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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