Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-31 @ 9:14 AM
Study NCT ID:
NCT06037395
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2023-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-05', 'releaseDate': '2024-04-08'}], 'estimatedResultsFirstSubmitDate': '2024-04-08'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A Randomized, Double-blind'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm, Parallel group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-07', 'studyFirstSubmitDate': '2023-09-07', 'studyFirstSubmitQcDate': '2023-09-07', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCinf', 'timeFrame': 'up to Day 253', 'description': 'Area under the concentration-time curve from time zero to infinity (AUC0-inf)'}, {'measure': 'AUClast', 'timeFrame': 'up to Day 253', 'description': 'Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)'}, {'measure': 'Cmax', 'timeFrame': 'up to Day 253', 'description': 'maximum serum concentration (Cmax)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CT-P41'], 'conditions': ['Healthy Subject']}, 'referencesModule': {'references': [{'pmid': '38349618', 'type': 'DERIVED', 'citation': 'Kim A, Hong JH, Shin W, Yoo H, Jung JG, Reginster JY, Kim S, Bae Y, Suh J, Kim S, Lee E, Silverman S. A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT-P41 and reference denosumab in healthy males. Expert Opin Biol Ther. 2024 Jul;24(7):655-663. doi: 10.1080/14712598.2024.2316846. Epub 2024 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects', 'detailedDescription': 'This study was a randomized, double-blind, two-arm, parallel group, single-dose, phase I study designed to compare PK, PD, safety, and immunogenicity between CT-P41 and US-licensed Prolia in healthy male subjects. Subjects were randomized into a 1:1 ratio to receive a single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for 253 days.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '28 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male subject, between the ages of 28 and 55 years, both inclusive\n2. Subject had a body mass index (BMI) between 18.5 and 29.9 kg/m2, both inclusive, and a body weight between 50.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.\n3. Subject with total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) and serum 25-OH vitamin D ≥ 20 ng/mL (≥ 50 nmol/L)\n\nExclusion Criteria:\n\n1. Subject was a female.\n2. Subject with a hypersensitivity to any component of denosumab or dry natural rubber (a derivative of latex).\n3. Subject was confirmed or suspected with infection of coronavirus disease 2019 (COVID-19) at screening, or had had contact with COVID-19 patient within 14 days from screening.\n4. Subject had a medical history of and/or current medical condition that can have effect on the study. Details to be discussed with investigator as per Protocol.\n\n 1. Subjects with known risk factors for hypocalcaemia\n 2. Subjects with known intolerance to calcium or vitamin D supplements\n 3. Subjects with known infection with active hepatitis B, hepatitis C, human immunodeficiency virus, or syphilis\n5. Subject had a history of and/or concurrent use of medications including any prior therapy that can have effect on the study. Details to be discussed with investigator as per Protocol.\n6. Subjects have or had any therapy that might significantly affect bone metabolism'}, 'identificationModule': {'nctId': 'NCT06037395', 'briefTitle': 'Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celltrion'}, 'officialTitle': 'A Randomized, Double-blind, Two-arm, Parallel Group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'CT-P41 1.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-P41', 'description': 'a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)', 'interventionNames': ['Biological: CT-P41']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'US-licensed Prolia', 'description': 'a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)', 'interventionNames': ['Biological: US-licensed Prolia']}], 'interventions': [{'name': 'CT-P41', 'type': 'BIOLOGICAL', 'description': 'a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)', 'armGroupLabels': ['CT-P41']}, {'name': 'US-licensed Prolia', 'type': 'BIOLOGICAL', 'description': 'a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)', 'armGroupLabels': ['US-licensed Prolia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13520', 'city': 'Seongnam', 'state': 'Bundang-gu', 'country': 'South Korea', 'facility': 'CHA Bundang Medical Center', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '35015', 'city': 'Daejeon', 'state': 'Jung-gu', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celltrion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-04-08', 'type': 'RELEASE'}, {'date': '2024-09-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Celltrion'}}}}