First Time in Man Trial for Friulimicin B

Status Terminated

Clinical Trial Summary

The purpose of this study is to study the safety of single doses and multiple doses of Friulimicin B in healthy volunteers. The level of Friulimicin B will be measured in the subjects blood and urine. One part of the study will assess if Friulimicin B in the plasma of subjects has activity against bacteria.

Clinical Trial Description

Continued widespread use of antibiotics has promoted the spread of antibiotic resistance and has created an urgent need for antibacterial agents with no known cross resistance to other antibiotics available for humans. Friulimicin B has been shown to be highly active against a range of bacteria including such important pathogens such as methicillin resistant Staphylococcus aureus (MRSA), drug resistant Streptococcus pneumoniae and Glycopeptide resistant Enterococcus spp. These organisms are the causative agents in serious infections such as skin and soft tissue infections, pneumonia, bacteremia and endocarditis, complicated urinary tract infections, and osteomyelitis.

This study is the first use of Friulimicin B in man and will examine its safety and a preliminary study will assess if Friulimicin B in the plasma of subjects has activity against bacteria. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00492271
Study type	Interventional
Source	MerLion Pharmaceuticals GmbH
Contact
Status	Terminated
Phase	Phase 1
Start date	June 2007
Completion date	September 2007

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