Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects

Inclusion Criteria: * Male or female 18 to 65 years of age * Female subjects must be postmenopausal or have a negative pregnancy test * Body weight in the range of ≥ 50 kg and ≤ 100 kg and have a body mass index of ≥ 18 to ≤ 32 kg/m2 Exclusion Criteria: * History of acute or chronic renal failure, thromboembolism, chronic respiratory illness, aseptic meningitis syndrome, or recurrent severe headaches or migraines. * Positive viral serology test for HIV -1/2 antibody, hepatitis B virus surface antigen, or hepatitis C virus antibody * Positive viral serology test for SARS-CoV-2 antibodies * Received any live viral or bacterial vaccinations within 8 weeks * Evidence of current active infection. * Known malignancy or a history of malignancy in the past 5 years * Female subject of childbearing potential or fertile male subject either not using or not willing to use an acceptable double barrier method of contraception to avoid pregnancy during the study