Phase I dose escalation study to evaluate the safety and pharmacokinetic profile of tefibazumab in subjects with end-stage renal disease requiring hemodialysis.
Two cohorts of four subjects requiring hemodialysis received tefibazumab (10 or 20 mg/kg). The mean elimination half-life was between 17 and 18 days, the average volume of distribution was 7.3 liters, and the average clearance was 12 ml/h for both dose groups. At a dose of 20 mg/kg of body weight, plasma levels were 88 microg/ml at 21 days.
Hetherington
Seth
S
Inhibex Inc, Alpharetta, GA, USA. shetherington@icagen.com
Texter
Michele
M
Wenzel
Eric
E
Patti
Joseph M
JM
Reynolds
Laurie
L
Shamp
Trish
T
Swan
Suzanne
S
D018829:Adhesins, Bacterial / Q000276:immunology*; D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D013203:Staphylococcal Infections / Q000628:therapy; D016896:Treatment Outcome
D018829:Adhesins, Bacterial; D000911:Antibodies, Monoclonal; C434058:clfB protein, Staphylococcus aureus