Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-25 @ 3:11 PM
Study NCT ID:
NCT05268068
Status:
COMPLETED
Last Update Posted:
2022-03-07
First Post:
2022-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601773', 'term': 'risankizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AE)', 'timeFrame': 'Up to Approximately 140 Days', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Maximum Observed Concentration (Cmax)', 'timeFrame': 'Up to Approximately 140 Days', 'description': 'Maximum observed concentration.'}, {'measure': 'Time to Cmax (Tmax)', 'timeFrame': 'Up to Approximately 140 Days', 'description': 'Time to Cmax.'}, {'measure': 'Terminal Phase Elimination Rate Constant (β)', 'timeFrame': 'Up to Approximately 140 Days', 'description': 'Terminal phase elimination rate constant.'}, {'measure': 'Terminal Phase Elimination Half-life (t1/2)', 'timeFrame': 'Up to Approximately 140 Days', 'description': 'Terminal phase elimination half-life.'}, {'measure': 'Area Under the Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)', 'timeFrame': 'Up to Approximately 140 Days', 'description': 'AUC from time 0 to time of the last measurable concentration (AUCt).'}, {'measure': 'AUC from Time 0 to Infinity (AUCinf)', 'timeFrame': 'Up to Approximately 140 Days', 'description': 'AUC from time 0 to infinity (AUCinf).'}, {'measure': 'Apparent Clearance (CL/F) for Subcutaneous (SC) dosing', 'timeFrame': 'Up to Approximately 140 Days', 'description': 'CL/F for SC dosing.'}, {'measure': 'Clearance (CL) for Intravenous (IV) Dosing', 'timeFrame': 'Up to Approximately 140 Days', 'description': 'CL for IV dosing.'}, {'measure': 'Number of Anti-drug antibody (ADA) Titers', 'timeFrame': 'Up to Approximately 140 Days', 'description': 'ADA titers will be tabulated for each participant at the respective study visits.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteers', 'Risankizumab', 'ABBV-066', 'SKYRIZI'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The objective of this study to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single subcutaneous (SC) or intravenous (IV) dose of risankizumab in healthy Chinese participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Body Mass Index (BMI) is \\>= 19.0 to \\<= 26.0 kg/m2 after rounding to the nearest tenth. BMI is calculated as weight in kg divided by the square of height measured in meters.\n\nExclusion Criteria:\n\n\\- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.'}, 'identificationModule': {'nctId': 'NCT05268068', 'briefTitle': 'A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1 Study in Healthy Chinese Subjects to Assess the Pharmacokinetics, Safety and Tolerability After a Single Dose of Risankizumab', 'orgStudyIdInfo': {'id': 'M17-381'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose A of Risankizumab for Subcutaneous (SC) Injection', 'description': 'Participants will receive SC injections of risankizumab at dose A and then followed for 140 days.', 'interventionNames': ['Drug: Risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose B of Risankizumab for Subcutaneous (SC) Injection', 'description': 'Participants will receive SC injections of risankizumab at dose B and then followed for 140 days.', 'interventionNames': ['Drug: Risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose C of Risankizumab for Intravenous (IV) Infusion', 'description': 'Participants will receive IV infusion of risankizumab at dose C and then followed for 140 days.', 'interventionNames': ['Drug: Risankizumab']}], 'interventions': [{'name': 'Risankizumab', 'type': 'DRUG', 'otherNames': ['ABBV-066', 'SKYRIZI'], 'description': 'Intravenous (IV) Infusion', 'armGroupLabels': ['Dose C of Risankizumab for Intravenous (IV) Infusion']}, {'name': 'Risankizumab', 'type': 'DRUG', 'otherNames': ['ABBV-066', 'SKYRIZI'], 'description': 'Subcutaneous (SC) Injection', 'armGroupLabels': ['Dose A of Risankizumab for Subcutaneous (SC) Injection', 'Dose B of Risankizumab for Subcutaneous (SC) Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200031', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Xuhui Central Hospital /ID# 212830', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}