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

CSL Behring

Status and phase

Terminated

Phase 1

Conditions

Coronavirus Disease 2019 (COVID-19)

Treatments

Biological: CSL760

Study type

Interventional

Funder types

Industry

Identifiers

NCT04638634

CSL760_1001

Details and patient eligibility

About

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).

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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