A safety and pharmacokinetic study of intravenous natalizumab in patients with MS.
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.
Sheremata
W A
WA
University of Miami, Department of Neurology, School of Medicine, FL 33136, USA. wsherema@mednet.med.miami.edu
Vollmer
T L
TL
Stone
L A
LA
Willmer-Hulme
A J
AJ
Koller
M
M
D000328:Adult; D015703:Antigens, CD / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D039441:Integrin alpha4; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*
D015703:Antigens, CD; D039441:Integrin alpha4