Back to resultsPharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
Primary Purpose
Coronavirus Disease 2019 (COVID-19)
Status
Terminated
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
CSL760
Sponsored by
About this trial
This is an interventional other trial for Coronavirus Disease 2019 (COVID-19)
Eligibility Criteria
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
Sites / Locations
- CMAX Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CSL760 (low dose)
CSL760 (high dose)
Arm Description
Administered as an intravenous infusion
Administered as an intravenous infusion
Outcomes
Primary Outcome Measures
Total immunoglobulin (IgG) concentration of CSL760
Maximum concentration (Cmax) of CSL760
Time of Cmax (tmax) of CSL760
Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last) of CSL760
Secondary Outcome Measures
Number of subjects with Treatment-emergent adverse events (TEAEs)
Percent of subjects with TEAEs
Number of subjects with Serious adverse events (SAEs)
Percent of subjects with SAEs
Number of subjects with Clinically significant laboratory abnormalities that are reported as adverse events (AEs)
Percent of subjects with Clinically significant laboratory abnormalities that are reported as AEs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04638634
Brief Title
Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
For business reasons, not a safety issue
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
June 9, 2021 (Actual)
Study Completion Date
June 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease 2019 (COVID-19)
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CSL760 (low dose)
Arm Type
Experimental
Arm Description
Administered as an intravenous infusion
Arm Title
CSL760 (high dose)
Arm Type
Experimental
Arm Description
Administered as an intravenous infusion
Intervention Type
Biological
Intervention Name(s)
CSL760
Other Intervention Name(s)
COVID-19 Immunoglobulin-VF
Intervention Description
An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin
Primary Outcome Measure Information:
Title
Total immunoglobulin (IgG) concentration of CSL760
Time Frame
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
Title
Maximum concentration (Cmax) of CSL760
Time Frame
Up to 91 days after end of IV infusion
Title
Time of Cmax (tmax) of CSL760
Time Frame
Up to 91 days after end of IV infusion
Title
Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last) of CSL760
Time Frame
Up to 91 days after end of IV infusion
Secondary Outcome Measure Information:
Title
Number of subjects with Treatment-emergent adverse events (TEAEs)
Time Frame
From start of infusion up to 91 days
Title
Percent of subjects with TEAEs
Time Frame
From start of infusion up to 91 days
Title
Number of subjects with Serious adverse events (SAEs)
Time Frame
From start of infusion up to 91 days
Title
Percent of subjects with SAEs
Time Frame
From start of infusion up to 91 days
Title
Number of subjects with Clinically significant laboratory abnormalities that are reported as adverse events (AEs)
Time Frame
From start of infusion up to 91 days
Title
Percent of subjects with Clinically significant laboratory abnormalities that are reported as AEs
Time Frame
From start of infusion up to 91 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
CSL Innovation Pty Ltd
Official's Role
Study Director
Facility Information:
Facility Name
CMAX Clinical Research
City
Adelaide
ZIP/Postal Code
SA 5000
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
IPD Sharing Time Frame
IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
IPD Sharing Access Criteria
Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.
An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.
The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
Learn more about this trial
Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
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