Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 4:53 PM
Study NCT ID:
NCT07367958
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P52 in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 218}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-20', 'studyFirstSubmitDate': '2026-01-09', 'studyFirstSubmitQcDate': '2026-01-20', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK similarity demonstration by AUC 0-inf', 'timeFrame': 'Day 85', 'description': 'Demonstrate the PK similarity in terms of area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P52 SC administration via AI versus PFS in healthy male subjects up to Day 85.'}, {'measure': 'PK similarity demonstration by Cmax', 'timeFrame': 'Day 85', 'description': 'Demonstrate the PK similarity in terms of maximum serum concentration (Cmax) of CT-P52 SC administration via AI versus PFS in healthy male subjects up to Day 85.'}], 'secondaryOutcomes': [{'measure': 'Additional PK evaluation by AUC0-last', 'timeFrame': 'Day 85', 'description': 'Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last).'}, {'measure': 'Additional PK evaluation by Tmax', 'timeFrame': 'Day 85', 'description': 'Evaluate additional PK in terms of time to maximum concentration (Tmax).'}, {'measure': 'Additional PK evaluation by T1/2', 'timeFrame': 'Day 85', 'description': 'Evaluate additional PK in terms of terminal half-life (t1/2).'}, {'measure': 'Additional PK evaluation by %AUCext', 'timeFrame': 'Day 85', 'description': 'Evaluate additional PK in terms of percentage of area under the concentration-time curve from time zero to infinity (AUC0-inf) obtained by extrapolation (%AUCext).'}, {'measure': 'Safety evaluation by AEs', 'timeFrame': 'Day 85', 'description': 'Evaluate safety in terms of adverse events (including treatment-emergent adverse events \\[TEAEs\\] and serious adverse events\\[SAEs\\]).'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Male Subjects']}, 'descriptionModule': {'briefSummary': 'This is phase 1 study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P52 in Healthy Male Subjects.', 'detailedDescription': 'CT-P52, containing the active ingredient ixekizumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Taltz. In this study, Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P52 will be evaluated in Healthy Male Subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects, between the ages of 19 and 55 years, both inclusive.\n* Subject has a body weight between 60 to 90 kg, both inclusive, and a BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth.\n\nExclusion Criteria:\n\n* A medical history and/or condition that is considered significant\n* Clinically significant allergic reactions, hypersensitivity\n* History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis\n* Active or latent Tuberculosis\n* History of malignancy\n* Previous exposure to ixekizumab or a biosimilar of ixekizumab or any drug that directly targets Interleukin (IL)-17 or the IL-17 receptor'}, 'identificationModule': {'nctId': 'NCT07367958', 'briefTitle': 'A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P52 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celltrion'}, 'officialTitle': 'A Phase 1, Randomized, Open-label, Two-arm, Parallel-Group, Single-dose Study to Compare Pharmacokinetics and Safety of CT-P52 AI and CT-P52 PFS in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'CT-P52 1.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-P52 Auto-injector', 'description': 'CT-P52, 80 mg in 1 ml, a single subcutaneous (SC) injection via auto-injector (AI)', 'interventionNames': ['Biological: CT-P52']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CT-P52 Pre-filled syringe', 'description': 'CT-P52, 80 mg in 1 ml, a single SC injection via pre-filled syringe (PFS)', 'interventionNames': ['Biological: CT-P52']}], 'interventions': [{'name': 'CT-P52', 'type': 'BIOLOGICAL', 'description': 'CT-P52, 80 mg in 1 ml, a single subcutaneous (SC) injection via auto-injector (AI)', 'armGroupLabels': ['CT-P52 Auto-injector', 'CT-P52 Pre-filled syringe']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celltrion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}