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

Sheremata, W A; Vollmer, T L; Stone, L A; Willmer-Hulme, A J; Koller, M · Neurology · 1999

rct · Level II

Where this comes from

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.

Medical subject headings