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A safety and pharmacokinetic study of intravenous natalizumab in patients with MS.

作者信息

Sheremata W A, Vollmer T L, Stone L A, Willmer-Hulme A J, Koller M

机构信息

University of Miami, Department of Neurology, School of Medicine, FL 33136, USA.

出版信息

Neurology. 1999 Mar 23;52(5):1072-4. doi: 10.1212/wnl.52.5.1072.

Abstract

A phase 1, randomized, placebo-controlled, five-level dose escalation safety and tolerability and pharmacokinetic study of a single IV dose of natalizumab was performed. Doses of 0.03 to 3.0 mg/kg natalizumab or placebo were studied in 28 stable relapsing-remitting or secondary-progressive MS. All doses were safe and well tolerated in MS. Serum concentrations of natalizumab are detectable for 3 to 8 weeks after a single 1- or 3-mg/kg IV dose and justify controlled efficacy studies.

摘要

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