Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT05283694
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2022-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants
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': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2022-03-09', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Up to 140 Days', 'description': 'Maximum Observed Plasma Concentration'}, {'measure': 'Time to maximum observed plasma concentration (Tmax)', 'timeFrame': 'Up to 140 Days', 'description': 'Time to maximum observed plasma concentration'}, {'measure': 'Area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt)', 'timeFrame': 'Up to 140 Days', 'description': 'AUC from time 0 to the time of last measurable concentration'}, {'measure': 'AUC from time 0 to infinity (AUCinf)', 'timeFrame': 'Up to 140 Days', 'description': 'AUC from time 0 to infinity'}, {'measure': 'Terminal phase elimination rate constant (β)', 'timeFrame': 'Up to 140 Days', 'description': 'Terminal phase elimination rate constant'}, {'measure': 'Terminal phase elimination half-life (t1/2).', 'timeFrame': 'Up to 140 Days', 'description': 'Terminal phase elimination half-life'}, {'measure': 'Number of Anti-drug antibody (ADA) Titers', 'timeFrame': 'Up to 140 Days', 'description': 'Incidence of anti-drug antibodies'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'Up to 140 Days', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight less than 100.00 kg inclusive at Screening and Check-In Day.\n* Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.\n\nExclusion Criteria:\n\n* Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.\n* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.'}, 'identificationModule': {'nctId': 'NCT05283694', 'briefTitle': 'A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Randomized Open-Label Single Dose Study to Evaluate the Effect of Rate and Volume of Administration on the Bioavailability of Risankizumab Following Subcutaneous (SC) Dosing in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'M16-324'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Risankizumab Dose A', 'description': 'Participants will receive 3 Subcutaneous (SC) injections of risankizumab Dose A administered via prepared syringe at Day 1 and followed for 140 days.', 'interventionNames': ['Drug: risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Risankizumab Dose B', 'description': 'Participants will receive 1 SC injection of risankizumab Dose B administered via syringe pump at Day 1 and followed for 140 days.', 'interventionNames': ['Drug: risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Risankizumab Dose C', 'description': 'Participants will receive 1 SC injection of risankizumab Dose C administered via syringe pump at Day 1 and followed for 140 days.', 'interventionNames': ['Drug: risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Risankizumab Dose D', 'description': 'Participants will receive 1 SC injection of risankizumab Dose D administered via prepared syringe at Day 1 and followed for 140 days.', 'interventionNames': ['Drug: risankizumab']}], 'interventions': [{'name': 'risankizumab', 'type': 'DRUG', 'otherNames': ['ABBV-066', 'SKYRIZI'], 'description': 'Subcutaneous Injection via prepared syringe', 'armGroupLabels': ['Risankizumab Dose A', 'Risankizumab Dose D']}, {'name': 'risankizumab', 'type': 'DRUG', 'otherNames': ['ABBV-066', 'SKYRIZI'], 'description': 'Subcutaneous Injection via syringe pump', 'armGroupLabels': ['Risankizumab Dose B', 'Risankizumab Dose C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60030', 'city': 'Grayslake', 'state': 'Illinois', 'country': 'United States', 'facility': 'Acpru /Id# 165737', 'geoPoint': {'lat': 42.34447, 'lon': -88.04175}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}