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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Coronavirus Disease 2019 (COVID-19)

Intervention / Treatment
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* Biological: CSL760


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSL760 (low dose)<br>Administered as an intravenous infusion | Biological: CSL760<br>* An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin<br>* Other names: COVID-19 Immunoglobulin-VF;|
| Experimental: CSL760 (high dose)<br>Administered as an intravenous infusion | Biological: CSL760<br>* An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin<br>* Other names: COVID-19 Immunoglobulin-VF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Maximum concentration (Cmax) of CSL760 |  | Up to 91 days after end of IV infusion | 
| Time of Cmax (tmax) of CSL760 |  | Up to 91 days after end of IV infusion | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Treatment-emergent adverse events (TEAEs) |  | From start of infusion up to 91 days | 
| Percent of subjects with TEAEs |  | From start of infusion up to 91 days | 
| Number of subjects with Serious adverse events (SAEs) |  | From start of infusion up to 91 days | 
| Percent of subjects with SAEs |  | From start of infusion up to 91 days | 
| Number of subjects with Clinically significant laboratory abnormalities that are reported as adverse events (AEs) |  | From start of infusion up to 91 days | 
| Percent of subjects with Clinically significant laboratory abnormalities that are reported as AEs |  | From start of infusion up to 91 days |