NCT01910883

Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: MerLion Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Finafloxacin i.v. solution 200 mg
DRUG	Finafloxacin i.v. solution 400 mg
DRUG	Finafloxacin i.v. solution 600 mg
DRUG	Finafloxacin i.v. solution 800 mg
DRUG	Finafloxacin i.v. solution 1000 mg
DRUG	Placebo i.v. solution

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2013-07-30
• Last updated: 2013-07-30

Locations

1 site across 1 country: United Kingdom