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

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


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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antigens, CD / administration & dosage
  • Antigens, CD / adverse effects
  • Antigens, CD / therapeutic use*
  • Female
  • Humans
  • Injections, Intravenous
  • Integrin alpha4
  • Male
  • Middle Aged
  • Multiple Sclerosis / drug therapy*


  • Antigens, CD
  • Integrin alpha4