Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-26 @ 8:49 PM
Study NCT ID:
NCT04570267
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2020-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2020-09-25', 'studyFirstSubmitQcDate': '2020-09-25', 'lastUpdatePostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum concentration (Cmax) of CSL324 in serum', 'timeFrame': 'From Day 1 to Day 56'}, {'measure': 'Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL324 in serum', 'timeFrame': 'From Day 1 to Day 56'}, {'measure': 'Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL324 in serum', 'timeFrame': 'From Day 1 to Day 56'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with treatment-emergent adverse events (TEAEs) by incidence, by severity, and by causality', 'timeFrame': 'Up to Day 56'}, {'measure': 'Percentage of subjects with TEAEs by incidence, by severity, and by causality', 'timeFrame': 'Up to Day 56'}, {'measure': 'Number of subjects with adverse events localized to the administration site by incidence, by severity, and by causality', 'timeFrame': 'Up to Day 7'}, {'measure': 'Percentage of subjects with adverse events localized to the administration site by incidence, by severity, and by causality', 'timeFrame': 'Up to Day 7'}, {'measure': 'Time to reach Cmax (Tmax) for CSL324 in serum', 'timeFrame': 'From Day 1 to Day 56'}, {'measure': 'Terminal half-life (t1/2) for CSL324 in serum', 'timeFrame': 'From Day 1 to Day 56'}, {'measure': 'Apparent clearance (CL/F) for CSL324 in serum', 'timeFrame': 'From Day 1 to Day 56'}, {'measure': 'Apparent volume of distribution (Vz/F) for CSL324 in serum', 'timeFrame': 'From Day 1 to Day 56'}, {'measure': 'Number of subjects with or without anti-CSL324 antibodies', 'timeFrame': 'Up to Day 56'}, {'measure': 'Percentage of subjects with or without anti-CSL324 antibodies', 'timeFrame': 'Up to Day 56'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Study CSL324\\_1003 is a single center, randomized, double-blind, placebo-controlled study designed to characterize and compare the PK properties and safety of a single subcutaneous dose of CSL324 in healthy Japanese and White subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female Japanese or White subjects aged 20 and 55 years, inclusive\n* Body weight of at least 45 kg to 100 kg, inclusive\n* Body mass index of 18.0 to 32.0 kg/m2, inclusive\n\nExclusion Criteria:\n\n* A clinically significant medical condition, disorder, or disease of any organ system.\n* Concurrent diagnosis of malignancy or history of malignancy (except for nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for at least 3 months before Screening).\n* Immunosuppressive conditions and / or currently taking immunosuppressive or immunomodulative therapy.\n* Clinically significant abnormalities on physical examination, vital signs, or laboratory assessments, or neutropenia (defined as absolute neutrophil count \\< 2.0 × 109/L).\n* History of chronic or recurrent infections, clinical signs of active infection and / or fever, current / history of serious infection or hospitalized or received IV antibiotics for an infection in previous 2 months.'}, 'identificationModule': {'nctId': 'NCT04570267', 'briefTitle': 'Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects', 'orgStudyIdInfo': {'id': 'CSL324_1003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSL324 (Low dose)', 'description': 'One low dose of CSL324 administered subcutaneously on Day 1', 'interventionNames': ['Biological: CSL324']}, {'type': 'EXPERIMENTAL', 'label': 'CSL324 (High dose)', 'description': 'One high dose of CSL324 administered subcutaneously on Day 1', 'interventionNames': ['Biological: CSL324']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One dose of placebo administered subcutaneously on Day 1', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CSL324', 'type': 'BIOLOGICAL', 'otherNames': ['Recombinant Anti G-CSF Receptor Monoclonal Antibody'], 'description': 'Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection', 'armGroupLabels': ['CSL324 (High dose)', 'CSL324 (Low dose)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sterile solution of CSL324 formulation buffer for injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Randwick', 'country': 'Australia', 'facility': 'Scientia Clinical Research Ltd', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Behring'}]}, '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'}}}}