 4. Female subjects must be of non-childbearing potential e.g., be confirmed postmenopausal or have undergone surgical sterilization or must, in conjunction with their sexual partners, use a highly effective contraceptive namely, a long-acting reversible method IUD, injectable, or implant, or a combination of oral contraception in conjunction with a male condom during the screening period and for at least 30 days after the infusion of study medication. 