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Antimicrobial Agents and Chemotherapy, October 2006, p. 3499-3500, Vol. 50, No. 10
0066-4804/06/$08.00+0     doi:10.1128/AAC.00407-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Phase I Dose Escalation Study To Evaluate the Safety and Pharmacokinetic Profile of Tefibazumab in Subjects with End-Stage Renal Disease Requiring Hemodialysis

Seth Hetherington,1* Michele Texter,1 Eric Wenzel,1 Joseph M. Patti,1 Laurie Reynolds,2 Trish Shamp,3 and Suzanne Swan4

Inhibitex, Inc., Alpharetta, Georgia,1 GloboMax, Division of Icon PLC, Ellicott City, Maryland,2 Prism Research, Inc., St. Paul, Minnesota,3 Hennepin County Medical Center and DaVita Clinical Research, Minneapolis, Minnesota4

Received 2 April 2006/ Returned for modification 19 May 2006/ Accepted 21 July 2006

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 µg/ml at 21 days.

* Corresponding author. Present address: Icagen, Inc., 4222 Emperor Boulevard, Durham, NC 27703. Phone: (919) 941-5206. Fax: (919) 941-7740. E-mail: shetherington{at}icagen.com.

Antimicrobial Agents and Chemotherapy, October 2006, p. 3499-3500, Vol. 50, No. 10
0066-4804/06/$08.00+0     doi:10.1128/AAC.00407-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.





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