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

A phase 1, randomized, placebo-controlled, five-level dose escalation safet y and tolerability and pharmacokinetic study of a single IV dose of nataliz umab 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 d oses were safe and well tolerated in MS. Serum concentrations of natalizuma b are detectable for 3 to 8 weeks after a single 1- or 3-mg/kg IV dose and justify controlled efficacy studies.