CSL760 is a human hyperimmune product of the purified gamma immunoglobulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). CSL is evaluating CSL760 as a passive immunotherapy for COVID-19 (Coronavirus Disease 2019).
Biological: CSL760
An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin
Other Name: COVID-19 Immunoglobulin-VF
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
CMAX Clinical Research
Adelaide, Australia
Study Director, Study Director
CSL Innovation Pty Ltd