Phase I dose escalation study to evaluate the safety and pharmacokinetic profile of tefibazumab in subjects with end-stage renal disease requiring hemodialysis |
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Authors: | Hetherington Seth Texter Michele Wenzel Eric Patti Joseph M Reynolds Laurie Shamp Trish Swan Suzanne |
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Affiliation: | Inhibex Inc, Alpharetta, GA, USA. shetherington@icagen.com |
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Abstract: | 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. |
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