First Time in Man Trial for Friulimicin B

MerLion Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Staphylococcal Skin Infections; Community Acquired Pneumonia

Treatments: Drug: Friulimicin B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00492271

CNB-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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31 participants in 1 patient group

1

Experimental group

Description:

Experimental arm with increasing dosage

Treatment:

Drug: Friulimicin B