Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT04638634
Status:
TERMINATED
Last Update Posted:
2021-12-10
First Post:
2020-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'For business reasons, not a safety issue', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-09', 'studyFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total immunoglobulin (IgG) concentration of CSL760', 'timeFrame': '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'}, {'measure': 'Maximum concentration (Cmax) of CSL760', 'timeFrame': 'Up to 91 days after end of IV infusion'}, {'measure': 'Time of Cmax (tmax) of CSL760', 'timeFrame': 'Up to 91 days after end of IV infusion'}, {'measure': 'Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last) of CSL760', 'timeFrame': 'Up to 91 days after end of IV infusion'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with Treatment-emergent adverse events (TEAEs)', 'timeFrame': 'From start of infusion up to 91 days'}, {'measure': 'Percent of subjects with TEAEs', 'timeFrame': 'From start of infusion up to 91 days'}, {'measure': 'Number of subjects with Serious adverse events (SAEs)', 'timeFrame': 'From start of infusion up to 91 days'}, {'measure': 'Percent of subjects with SAEs', 'timeFrame': 'From start of infusion up to 91 days'}, {'measure': 'Number of subjects with Clinically significant laboratory abnormalities that are reported as adverse events (AEs)', 'timeFrame': 'From start of infusion up to 91 days'}, {'measure': 'Percent of subjects with Clinically significant laboratory abnormalities that are reported as AEs', 'timeFrame': 'From start of infusion up to 91 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Disease 2019 (COVID-19)']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 18 to 65 years of age\n* Female subjects must be postmenopausal or have a negative pregnancy test\n* Body weight in the range of ≥ 50 kg and ≤ 100 kg and have a body mass index of ≥ 18 to ≤ 32 kg/m2\n\nExclusion Criteria:\n\n* History of acute or chronic renal failure, thromboembolism, chronic respiratory illness, aseptic meningitis syndrome, or recurrent severe headaches or migraines.\n* Positive viral serology test for HIV -1/2 antibody, hepatitis B virus surface antigen, or hepatitis C virus antibody\n* Positive viral serology test for SARS-CoV-2 antibodies\n* Received any live viral or bacterial vaccinations within 8 weeks\n* Evidence of current active infection.\n* Known malignancy or a history of malignancy in the past 5 years\n* 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'}, 'identificationModule': {'nctId': 'NCT04638634', 'briefTitle': 'Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CSL760_1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSL760 (low dose)', 'description': 'Administered as an intravenous infusion', 'interventionNames': ['Biological: CSL760']}, {'type': 'EXPERIMENTAL', 'label': 'CSL760 (high dose)', 'description': 'Administered as an intravenous infusion', 'interventionNames': ['Biological: CSL760']}], 'interventions': [{'name': 'CSL760', 'type': 'BIOLOGICAL', 'otherNames': ['COVID-19 Immunoglobulin-VF'], 'description': 'An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin', 'armGroupLabels': ['CSL760 (high dose)', 'CSL760 (low dose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SA 5000', 'city': 'Adelaide', 'country': 'Australia', 'facility': 'CMAX Clinical Research', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Innovation Pty Ltd'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '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.', 'ipdSharing': 'YES', '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.\n\nApplicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.\n\nIf the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.', 'accessCriteria': "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.\n\nAn 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.\n\nThe requesting party must execute an appropriate data sharing agreement before IPD will be made available."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}