Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT05110118
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '2021-10-25', 'studyFirstSubmitQcDate': '2021-10-27', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC0-t）', 'timeFrame': 'From baseline to Day 99'}, {'measure': 'Area under the plasma concentration-time curve from time zero to infinity（AUC0-∞）', 'timeFrame': 'From baseline to Day 99'}, {'measure': 'Maximum (peak) plasma concentration（Cmax）', 'timeFrame': 'From baseline to Day 99'}, {'measure': 'Chloride（CL）', 'timeFrame': 'From baseline to Day 99'}, {'measure': 'Terminal elimination half-life（t1/2）', 'timeFrame': 'From baseline to Day 99'}, {'measure': 'Apparent volume of distribution（Vd）', 'timeFrame': 'From baseline to Day 99'}], 'secondaryOutcomes': [{'measure': 'Adverse Events(AEs)', 'timeFrame': 'From baseline to Day 99'}, {'measure': 'Vital signs', 'timeFrame': 'From baseline to Day 99'}, {'measure': 'Physical examinations', 'timeFrame': 'From baseline to Day 99'}, {'measure': 'Clinical laboratory tests', 'timeFrame': 'From baseline to Day 99'}, {'measure': '12-lead ECGs', 'timeFrame': 'From baseline to Day 99'}, {'measure': 'Positive rate of serum anti-drug antibody (ADA)', 'timeFrame': 'From baseline to Day 99'}, {'measure': 'Positive rate of neutralizing antibody (NAb)', 'timeFrame': 'From baseline to Day 99'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Colorectal Cancer', 'Non Small Cell Lung Cancer Metastatic', 'Non Small Cell Lung Cancer Recurrent']}, 'referencesModule': {'references': [{'pmid': '34913787', 'type': 'DERIVED', 'citation': 'Zhou R, Yang J, Liu Y, Zhang Q, Lu C, Tang K, Li X, Tang W, Gao E, Wu C, Dou C, Hu W. A randomized, double-blind, parallel-group phase I study comparing the pharmacokinetics, safety, and immunogenicity of LY01008, a candidate bevacizumab biosimilar, with its reference product Avastin(R) in healthy Chinese male subjects. Expert Opin Biol Ther. 2022 Feb;22(2):263-269. doi: 10.1080/14712598.2022.2019703. Epub 2021 Dec 27.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, single-dose, parallel-group study comparing pharmacokinetic characteristics, safety , tolerability and immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in healthy Chinese male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers\n* Subjects aged 18 - 45 years\n* Subjects weighing ≥ 50.0 kg and ≤ 100.0 kg\n* Subjects with a body mass index (BMI) ≥ 19.0 and ≤ 26.0 kg/m2\n\nExclusion Criteria:\n\n* Subjects with evidence or history of clinically significant disease\n* Subjects with a history of previous cancer\n* Subjects with a history of hypertension, or abnormal blood pressure at screening/baseline measurements (systolic blood pressure \\> 140 mmHg and/or diastolic blood pressure \\> 90 mmHg confirmed by a repeat measurement on the same day)\n* Subjects with a history of blood donation 3 months before study drug infusion\n* Subjects with a history of exposure to antibodies 12 months before study drug infusion\n* Subjects with previous exposure to anti-VEGF therapy'}, 'identificationModule': {'nctId': 'NCT05110118', 'briefTitle': 'Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Boan Biotechnology Co., Ltd'}, 'officialTitle': 'A Randomized, Double-blind, Single-dose, Parallel-group Study Comparing Pharmacokinetic Characteristics, Safety , Tolerability and Immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in Healthy Chinese Male Subjects', 'orgStudyIdInfo': {'id': 'LY01008/CT-CHN-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY01008', 'description': 'Single intravenous injection of LY01008 3 mg/kg for 90 min(±1 min).', 'interventionNames': ['Drug: LY01008']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Avastin', 'description': 'Single intravenous injection of Avastin 3 mg/kg for 90 min(±1 min).', 'interventionNames': ['Drug: Avastin']}], 'interventions': [{'name': 'LY01008', 'type': 'DRUG', 'otherNames': ['Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection'], 'description': 'Single intravenous injection', 'armGroupLabels': ['LY01008']}, {'name': 'Avastin', 'type': 'DRUG', 'otherNames': ['Bevacizumab'], 'description': 'Single intravenous injection', 'armGroupLabels': ['Avastin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The Second Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Boan Biotechnology Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}