Finafloxacin - A Double-blind, Placebo-controlled, Randomised, Dose-escalating, Crossover Study to Determine the Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects

NCT01910883 Phase 1 COMPLETED

This is the first time finafloxacin was administered to humans intravenously. The principal aim of this study was to obtain safety and tolerability data when finafloxacin was administered intravenously as single and multiple doses to healthy subjects.

Details

Lead sponsor	MerLion Pharmaceuticals GmbH
Phase	Phase 1
Status	COMPLETED
Enrolment	58
Start date	2010-09
Completion	2012-03

Conditions

• Healthy

Interventions

• Finafloxacin i.v. solution 200 mg
• Finafloxacin i.v. solution 400 mg
• Finafloxacin i.v. solution 600 mg
• Finafloxacin i.v. solution 800 mg
• Finafloxacin i.v. solution 1000 mg
• Placebo i.v. solution

Primary outcomes

• Safety — 1 to 7 days
  The primary objective was to evaluate the safety and tolerability of single and multiple intravenous (IV) doses of finafloxacin in healthy subjects. The safety evaluation includes the descriptive display and analysis of adverse events after single and multiple doses for 7 days of intravenously administered finafloxacin. The frequency of adverse events is evaluated for all casualties and for drug related adverse events. Comparisons between the placebo and verum groups are provided in descriptive manner. In addition the evaluation of clinical laboratory data, vital signs, electrocardiography data, physical examination, local tolerability is provided.

Countries

United Kingdom