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