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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00492271
Other study ID # CNB-001
Secondary ID
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


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
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