Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-03-06 @ 2:31 PM
Study NCT ID:
NCT04411550
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2020-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2020-05-31', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'from predose to 2352 hours (Day 99),13 timepoints', 'description': 'Peak concentration'}, {'measure': 'AUC0~t', 'timeFrame': 'from predose to 2352 hours (Day 99),13 timepoints', 'description': 'Area under the plasma concentration-time curve from time 0 to the last concentration-measurable time point'}, {'measure': 'AUC0~inf', 'timeFrame': 'from predose to 2352 hours (Day 99),13 timepoints', 'description': 'Area under the plasma concentration-time curve from time 0 to infinity'}], 'secondaryOutcomes': [{'measure': 'safety and tolerability of 4 groups', 'timeFrame': 'from day1 to day 99', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0'}, {'measure': 'safety and tolerability of 4 groups', 'timeFrame': 'from day1 to day 99', 'description': 'Number of AE as assessed by CTCAE v5.0'}, {'measure': 'safety and tolerability of two groups', 'timeFrame': 'from day1 to day 99', 'description': 'AE listing as assessed by CTCAE v5.0'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Male Volunteers']}, 'referencesModule': {'references': [{'pmid': '35132630', 'type': 'RESULT', 'citation': 'American Society for Clinical Pharmacology and Therapeutics. Clin Pharmacol Ther. 2022 Mar;111 Suppl 1:S5-S80. doi: 10.1002/cpt.2521. No abstract available.'}, {'pmid': '35594017', 'type': 'DERIVED', 'citation': 'Yang J, Lin L, Long Q, Zhang Q, Sun G, Zhou L, Wang Q, Zhu J, Li F, Hu W. HLX11, a Proposed Pertuzumab Biosimilar: Pharmacokinetics, Immunogenicity, and Safety Profiles Compared to Three Reference Biologic Products (US-, EU-, and CN-Approved Pertuzumab) Administered to Healthy Male Subjects. BioDrugs. 2022 May;36(3):393-409. doi: 10.1007/s40259-022-00534-w. Epub 2022 May 20.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Chinese males\n* aged ≥ 18 and ≤ 45\n* body mass index (BMI) ≥ 19 and ≤ 26 kg/m2\n* LVEF≥ 55%\n\nExclusion Criteria:\n\n* A history of any serious clinical disease such as haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological diseases, and tumour, or allergic diseases\n* Use of a monoclonal antibody or any biological product within 6 months before study drug administration\n* A history of allergic reactions or anaphylaxis, including such reactions to any drug or excipient in the clinical study\n* Use of prescription drugs, over-the-counter drugs (OTC), or traditional Chinese medicine (TCM) (excluding vitamins, mineral supplements, and dietary supplements) within 28 days before study drug administration\n* A history of blood donation within 3 months before study drug administration\n* Participation in other clinical study and use of the investigational product/comparator within 3 months before study drug administration\n* Positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody\n* A history of drug abuse\n* Failure to comply with protocol requirements, instructions, and study limitations, such as uncooperative attitude, failure to return to the study site for follow-up visits, or failure to complete the entire clinical study, as judged by investigators'}, 'identificationModule': {'nctId': 'NCT04411550', 'briefTitle': 'Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Henlius Biotech'}, 'officialTitle': 'A (Randomised, Double-Blind, Intravenous Single-Dose, Parallel, Four-Arm) Phase I Clinical Study to Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta® (US, EU, and CN-Sourced) in Healthy Chinese Male Subjects', 'orgStudyIdInfo': {'id': 'HLX11-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HLX11 group', 'description': 'HLX11 are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).', 'interventionNames': ['Drug: HLX11']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CN-Perjeta group', 'description': 'CN-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).', 'interventionNames': ['Drug: CN-Perjeta(Pertuzumab)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EU-Perjeta group', 'description': 'EU-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).', 'interventionNames': ['Drug: EU-Perjeta(Pertuzumab)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'US-Perjeta group', 'description': 'US-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).', 'interventionNames': ['Drug: US-Perjeta(Pertuzumab)']}], 'interventions': [{'name': 'HLX11', 'type': 'DRUG', 'description': 'healthy volunteers receive HLX11 (420mg) once', 'armGroupLabels': ['HLX11 group']}, {'name': 'CN-Perjeta(Pertuzumab)', 'type': 'DRUG', 'description': 'healthy volunteers receive CN-Perjeta (420mg) once', 'armGroupLabels': ['CN-Perjeta group']}, {'name': 'EU-Perjeta(Pertuzumab)', 'type': 'DRUG', 'description': 'healthy volunteers receive EU-Perjeta (420mg) once', 'armGroupLabels': ['EU-Perjeta group']}, {'name': 'US-Perjeta(Pertuzumab)', 'type': 'DRUG', 'description': 'healthy volunteers receive US-Perjeta (420mg) once', 'armGroupLabels': ['US-Perjeta group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The Second Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'overallOfficials': [{'name': 'Wei Hu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Anhui Medical University'}, {'name': 'Hui Zhao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Anhui Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Henlius Biotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}