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

Coronavirus Disease 2019 (COVID-19) Clinical Trial

Official title:

A Single Center, Phase 1, Single-Ascending Dose, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04638634
• Other study ID #: CSL760_1001
• Status: Terminated
• Phase: Phase 1
• Start date: February 2, 2021
• Est. completion date: June 9, 2021

Study information

• Verified date: December 2021
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 9, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Disease 2019 (COVID-19)
• COVID-19

Intervention

Biological:
• CSL760
An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin

Locations

Country	Name	City	State
Australia	CMAX Clinical Research	Adelaide

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total immunoglobulin (IgG) concentration of CSL760		At 0,0.5,1,2,6,12,24, and 48 hours, and 7,14,28,49, and 91 days after end of IV infusion
Primary	Maximum concentration (Cmax) of CSL760		Up to 91 days after end of IV infusion
Primary	Time of Cmax (tmax) of CSL760		Up to 91 days after end of IV infusion
Primary	Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last) of CSL760		Up to 91 days after end of IV infusion
Secondary	Number of subjects with Treatment-emergent adverse events (TEAEs)		From start of infusion up to 91 days
Secondary	Percent of subjects with TEAEs		From start of infusion up to 91 days
Secondary	Number of subjects with Serious adverse events (SAEs)		From start of infusion up to 91 days
Secondary	Percent of subjects with SAEs		From start of infusion up to 91 days
Secondary	Number of subjects with Clinically significant laboratory abnormalities that are reported as adverse events (AEs)		From start of infusion up to 91 days
Secondary	Percent of subjects with Clinically significant laboratory abnormalities that are reported as AEs		From start of infusion up to 91 days