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

NCT01910883 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2013-07-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • MerLion Pharmaceuticals GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01910883 on ClinicalTrials.gov