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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04638634
Recruitment Status : Terminated (For business reasons, not a safety issue)
First Posted : November 20, 2020
Last Update Posted : December 10, 2021
Sponsor:
Information provided by (Responsible Party):
CSL Behring

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).

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 (COVID-19) Biological: CSL760 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : February 2, 2021
Actual Primary Completion Date : June 9, 2021
Actual Study Completion Date : June 9, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CSL760 (low dose)
Administered as an intravenous infusion
Biological: CSL760
An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin
Other Name: COVID-19 Immunoglobulin-VF

Experimental: CSL760 (high dose)
Administered as an intravenous infusion
Biological: CSL760
An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin
Other Name: COVID-19 Immunoglobulin-VF




Primary Outcome Measures :
  1. 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 ]
  2. Maximum concentration (Cmax) of CSL760 [ Time Frame: Up to 91 days after end of IV infusion ]
  3. Time of Cmax (tmax) of CSL760 [ Time Frame: Up to 91 days after end of IV infusion ]
  4. 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 Measures :
  1. Number of subjects with Treatment-emergent adverse events (TEAEs) [ Time Frame: From start of infusion up to 91 days ]
  2. Percent of subjects with TEAEs [ Time Frame: From start of infusion up to 91 days ]
  3. Number of subjects with Serious adverse events (SAEs) [ Time Frame: From start of infusion up to 91 days ]
  4. Percent of subjects with SAEs [ Time Frame: From start of infusion up to 91 days ]
  5. 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 ]
  6. Percent of subjects with Clinically significant laboratory abnormalities that are reported as AEs [ Time Frame: From start of infusion up to 91 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638634


Locations
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Australia
CMAX Clinical Research
Adelaide, Australia, SA 5000
Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Director CSL Innovation Pty Ltd
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT04638634    
Other Study ID Numbers: CSL760_1001
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: December 10, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs