A Phase 1 interventional study of Friulimicin B in Community Acquired Pneumonia and Staphylococcal Skin Infections, sponsored by MerLion Pharmaceuticals GmbH. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-07-23.
Sponsored by MerLion Pharmaceuticals GmbH · Phase 1, Interventional, and Treatment
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.
91 studies on the registry are indexed under Community-Acquired Pneumonia; 54 are open to participants now.
This study's enrollment of 31 is below the median of 307 across 59 interventional studies indexed under Community-Acquired Pneumonia.
Browse Community-Acquired Pneumonia studies →MerLion Pharmaceuticals GmbH is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Experimental arm with increasing dosage
Drug: Friulimicin B
Intravenous, once daily, single dose
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.
Time frame: 5 days
To determine the pharmacokinetic profile of single and multiple intravenous doses of Friulimicin B in healthy subjects
Time frame: 5 days
To determine the bactericidal activity of serum obtained from healthy subjects after administration of Friulimicin B
Time frame: 5 days
This study is terminated, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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Community-Acquired Pneumonia →
MerLion Pharmaceuticals GmbH