Journal
CURRENT MEDICAL RESEARCH AND OPINION
Volume 22, Issue 9, Pages 1671-1678Publisher
LIBRAPHARM
DOI: 10.1185/030079906X120931
Keywords
interieukin-12/23; monoclonal antibodies; multiple sclerosis; relapsing-remitting
Ask authors/readers for more resources
Objective: To assess the safety, tolerability and pharmacokinetics of an interleukin (IL)-12/23 monoclonal antibody (mAb) in subjects with a relapsing form of multiple sclerosis (MS). Methods: A phase I, double-blind, placebo-controlled, sequential dose escalation study was conducted in 20 subjects with MS. Subjects were randomized (4:1) to receive a single subcutaneous injection of either IL-12/23 mAb (0.3, 0.75, 1.5, and 3.0mg/kg) or placebo. Clinical and laboratory evaluations were performed through 16 weeks following administration. Results: IL-12/23 mAb was well tolerated in this study. Adverse events were generally mild or moderate, with no apparent dose-related trends. One subject with a family history of breast cancer was diagnosed during the study with breast cancer 21 days after IL-12/23 mAb administration. There were no significant changes in laboratory indicators of systemic or neurotoxicity. There was a large degree of variability in T2 lesion volume and total number of gadolinium-positive lesions, both unaffected by dose escalation. Three relapses of MS occurred in two placebo-treated subjects. Over the range of single doses studied, the median T-max ranged from 9.0 to 16.5 days, and the median T-1/2 ranged from 20.2 to 30.9 days. Conclusion: Single subcutaneous administrations of IL-12/23 mAb in this first study of relapsing MS were generally well tolerated. Safety of the agent will need to be tested in a study of longer duration and involving a larger cohort of subjects.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available