First Time in Man Trial for Friulimicin B

Community Acquired Pneumonia Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Randomized, Dose-Escalating Study of Single (Part A) and Multiple (Part B) Intravenous Doses of Friulimicin B in Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00492271
• Other study ID #: CNB-001
• Status: Terminated
• Phase: Phase 1
• First received: June 25, 2007
• Last updated: July 22, 2008
• Start date: June 2007
• Est. completion date: September 2007

Study information

• Verified date: July 2008
• Source: MerLion Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

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

• Community Acquired Pneumonia
• Pneumonia
• Skin Diseases, Infectious
• Staphylococcal Skin Infections

Intervention

Drug:
• Friulimicin B
Intravenous, once daily, single dose

Locations

Country	Name	City	State
Switzerland	Swiss Pharma Contract Ltd	Basel

Sponsors (1)

Lead Sponsor	Collaborator
MerLion Pharmaceuticals GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the pharmacokinetic profile of single and multiple intravenous doses of Friulimicin B in healthy subjects		5 days
Secondary	To determine the bactericidal activity of serum obtained from healthy subjects after administration of Friulimicin B		5 days