Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-01-04 @ 5:05 PM
Study NCT ID:
NCT06571266
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2024-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult 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': 231}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2024-08-23', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to day 140', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of Risankizumab', 'timeFrame': 'Up to Day 140', 'description': 'Cmax will be assessed of Risankizumab'}, {'measure': 'Time to Cmax (Tmax) of Risankizumab', 'timeFrame': 'Up to Day 140', 'description': 'Tmax will be assessed of Risankizumab'}, {'measure': 'Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab', 'timeFrame': 'Up to Day 140', 'description': 'Apparent terminal phase elimination rate constant (β) will be assessed of Risankizumab'}, {'measure': 'Terminal Phase Elimination Half-life (t1/2) of Risankizumab', 'timeFrame': 'Up to Day 140', 'description': 'Terminal phase elimination half-life (t1/2) will be assessed of Risankizumab'}, {'measure': 'Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)', 'timeFrame': 'Up to Day 140', 'description': 'AUC0-t will be assessed'}, {'measure': 'AUC from Time 0 to Infinity (AUC0-inf) of Risankizumab', 'timeFrame': 'Up to Day 140', 'description': 'AUC0-inf will be assessed of Risankizumab'}, {'measure': 'Number of Anti-drug antibody (ADA) Titers', 'timeFrame': 'Up to Day 140', 'description': 'Incidence and concentration of anti-drug antibodies'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteers', 'Risankizumab', 'ABBV-066'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M24-342', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight 40 kg to 100 kg, inclusive, at screening and upon initial confinement\n* Body Mass Index (BMI) is \\> = 18.0 to \\< = 32.0 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.\n\nExclusion Criteria:\n\n* Participant with exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment for at least one year prior to Screening.\n* Participant with intention to perform strenuous exercise within at least one week prior to administration of study drug or during the study.\n* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.'}, 'identificationModule': {'nctId': 'NCT06571266', 'briefTitle': 'A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes', 'orgStudyIdInfo': {'id': 'M24-342'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Risankizumab Formulation 1', 'description': 'Participants will receive a single dose of Risankizumab formulation 1 on day 1.', 'interventionNames': ['Drug: Risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Risankizumab Formulation 2', 'description': 'Participants will receive a single dose of Risankizumab formulation 2 on day 1.', 'interventionNames': ['Drug: Risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Risankizumab Formulation 3', 'description': 'Participants will receive a single dose of Risankizumab formulation 3 on day 1.', 'interventionNames': ['Drug: Risankizumab']}], 'interventions': [{'name': 'Risankizumab', 'type': 'DRUG', 'otherNames': ['ABBV-066', 'SKYRIZI'], 'description': '• Subcutaneous Injection via prefilled syringe', 'armGroupLabels': ['Risankizumab Formulation 1', 'Risankizumab Formulation 2', 'Risankizumab Formulation 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Cenexel Act /ID# 270310', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Research CNS /ID# 270286', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '60030', 'city': 'Grayslake', 'state': 'Illinois', 'country': 'United States', 'facility': 'Acpru /Id# 270152', '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'}}}}