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

Seth Hetherington | Zendy; Michele Texter | Zendy; Eric Wenzel | Zendy; Joseph M. Patti | Zendy; Laurie Reynolds | Zendy; Trish Shamp | Zendy; Suzanne K. Swan | Zendy

Open Access

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

Author(s) -

Seth Hetherington,

Michele Texter,

Eric Wenzel,

Joseph M. Patti,

Laurie Reynolds,

Trish Shamp,

Suzanne K. Swan

Publication year - 2006

Publication title -

antimicrobial agents and chemotherapy

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 2.07

H-Index - 259

eISSN - 1070-6283

pISSN - 0066-4804

DOI - 10.1128/aac.00407-06

Subject(s) - hemodialysis , pharmacokinetics , end stage renal disease , medicine , volume of distribution , body weight , urology , pharmacology

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.

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