First Time in Man Trial for Friulimicin B

Phase 1

Terminated

• Conditions: Community Acquired Pneumonia; Staphylococcal Skin Infections
• Interventions: Drug: Friulimicin B

• Registration Number: NCT00492271
• Lead Sponsor: MerLion Pharmaceuticals GmbH

Brief 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.

Detailed 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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-25
• Study First Submitted QC: 2007-06-25
• Study First Posted: 2007-06-27
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-22
• Last Update Posted: 2008-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Male or female healthy subjects
• 18-55 years of age
• In good health

Exclusion Criteria

• Abnormal physical findings of clinical significance at the Screening examination or baseline which would interfere with the objectives of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Friulimicin B	Experimental arm with increasing dosage

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of single and multiple intravenous doses of Friulimicin B by assessing adverse events, physical examinations,clinical chemistry examination, hematology, ECG and urinalysis.	5 days

Secondary Outcome Measures

Name	Time	Method
To determine the bactericidal activity of serum obtained from healthy subjects after administration of Friulimicin B	5 days
To determine the pharmacokinetic profile of single and multiple intravenous doses of Friulimicin B in healthy subjects	5 days

Trial Locations

Locations (1)

Swiss Pharma Contract Ltd; 🇨🇭 Basel, Switzerland