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

Author(s): Sheremata WA, Vollmer TL, Stone LA, Willmer-Hulme AJ, Koller M

Affiliation(s): University of Miami, Department of Neurology, School of Medicine, FL 33136, USA. wsherema@mednet.med.miami.edu

Publication date & source: 1999-03-23, Neurology., 52(5):1072-4.

Publication type: Clinical Trial; Clinical Trial, Phase I; Randomized Controlled Trial

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.

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