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

NCT01910883 ↗

Phase 1 Completed 58 enrolled MerLion Pharmaceuticals GmbH

RandomizedCrossoverTriple-blindTreatment

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.

Timeline

Start: 2010-09
Primary completion: 2012-03
Completion: 2012-03

Publications

Taubert M, Chiesa J, Luckermann M, Fischer C, Dalhoff A, Fuhr U. Pharmacokinetics of Intravenous Finafloxacin in Healthy Volunteers. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e01122-17. doi: 10.1128/AAC.01122-17. Print 2017 Oct.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Finafloxacin	Small molecule	200 mg	Intravenous
Subject	Finafloxacin	Small molecule	400 mg	Intravenous
Subject	Finafloxacin	Small molecule	600 mg	Intravenous
Subject	Finafloxacin	Small molecule	800 mg	Intravenous
Subject	Finafloxacin	Small molecule	1000 mg	Intravenous

Indications

No indication recorded.