All study screening data from Visit 1 including laboratory results must be reviewed for study eligibility prior to receiving first dose of study drug. Prior to infusion, a review of concomitant medications and AEs takes place. If the subject continues to be eligible for enrollment, the subject will be infused with study medication and will remain in the infusion clinic for at least 1 hour following the infusion for safety assessments on Visit 2 (Day 1), and 15 minutes for the subsequent visits.