Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-22 @ 5:32 PM
Study NCT ID:
NCT04027803
Status:
COMPLETED
Last Update Posted:
2020-05-15
First Post:
2019-07-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C481642', 'term': 'eculizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'morozovama@biocad.ru', 'phone': '+7 (495) 992 66 28', 'title': 'Morozova Maria', 'phoneExt': '8436', 'organization': 'BIOCAD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '82 days', 'eventGroups': [{'id': 'EG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 28, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 31, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'eosinophils count increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lymphocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'monocytes count increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'platelet count decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ESR increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INR decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'prothrombin time decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'prothrombin time increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC0-∞ of Eculizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '104346442.41', 'groupId': 'OG000', 'lowerLimit': '86711718.872', 'upperLimit': '138234664.3'}, {'value': '114291981.79', 'groupId': 'OG001', 'lowerLimit': '95801210.959', 'upperLimit': '126281914.98'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'AUC0-∞ of eculizumab (the area under the Concentration vs. Time curve from 0 to infinity)', 'unitOfMeasure': '(ng/ml)*hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cmax of Eculizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '102466648.13', 'groupId': 'OG000', 'lowerLimit': '86216316.914', 'upperLimit': '130773188.67'}, {'value': '112710712.24', 'groupId': 'OG001', 'lowerLimit': '95318606.352', 'upperLimit': '125562084.16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Cmax of eculizumab (maximum concentration of eculizumab in the serum)', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Тmax of Eculizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '12'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '0.083', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Тmax of eculizumab (time to Cmax)', 'unitOfMeasure': 'hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC0-1392 of Eculizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '102466648.13', 'groupId': 'OG000', 'lowerLimit': '86216316.914', 'upperLimit': '130773188.67'}, {'value': '112710712.24', 'groupId': 'OG001', 'lowerLimit': '95318606.352', 'upperLimit': '125562084.16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'AUC0-1392 of eculizumab (the area under the Concentration vs. Time curve from 0 to 1392 h post-infusion)', 'unitOfMeasure': '(ng/ml)*hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Т1/2 of Eculizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '165.429', 'groupId': 'OG000', 'lowerLimit': '154.479', 'upperLimit': '198.042'}, {'value': '161.61', 'groupId': 'OG001', 'lowerLimit': '132.711', 'upperLimit': '209.22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Т1/2 of eculizumab (half-life)', 'unitOfMeasure': 'hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vd of Eculizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '2595.302', 'groupId': 'OG000', 'lowerLimit': '2118.734', 'upperLimit': '3434.689'}, {'value': '2620.503', 'groupId': 'OG001', 'lowerLimit': '1973.187', 'upperLimit': '2984.036'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Vd of eculizumab (steady-state volume of distribution)', 'unitOfMeasure': 'ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Кel of Eculizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '0.004', 'groupId': 'OG000', 'lowerLimit': '0.004', 'upperLimit': '0.004'}, {'value': '0.004', 'groupId': 'OG001', 'lowerLimit': '0.003', 'upperLimit': '0.005'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Кel of eculizumab (elimination constant)', 'unitOfMeasure': '1/h', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cl of Eculizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '8.783', 'groupId': 'OG000', 'lowerLimit': '6.882', 'upperLimit': '10.439'}, {'value': '7.985', 'groupId': 'OG001', 'lowerLimit': '7.168', 'upperLimit': '9.442'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Cl of eculizumab (clearance)', 'unitOfMeasure': 'ml/(h*kg)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ABEC(0-1392) CH50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '-33606.865', 'groupId': 'OG000', 'lowerLimit': '-51185.201', 'upperLimit': '-20772.736'}, {'value': '-37244.026', 'groupId': 'OG001', 'lowerLimit': '-49459.807', 'upperLimit': '-25247.772'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'ABEC(0-1392) CH50 (the area between the baseline and effect curves for hemolytic activity of serum complement from 0 to 1392 h)', 'unitOfMeasure': '(%)*h', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUEC(0-1392) CH50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '61600.835', 'groupId': 'OG000', 'lowerLimit': '45529.369', 'upperLimit': '75529.787'}, {'value': '53479.141', 'groupId': 'OG001', 'lowerLimit': '40111.132', 'upperLimit': '72474.492'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'AUEC(0-1392) CH50 ((area under the Time vs. Effect curve from 0 to 1392 h)', 'unitOfMeasure': '(%)*h', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Emin CH50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Emin CH50 (minimum hemolytic complement activity from 0 to 1392 h)', 'unitOfMeasure': '% of hemolitic activity', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tmin CH50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '0.083', 'groupId': 'OG000', 'lowerLimit': '0.083', 'upperLimit': '0.083'}, {'value': '0.083', 'groupId': 'OG001', 'lowerLimit': '0.083', 'upperLimit': '0.083'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Tmin CH50 (time to minimum hemolytic complement activity within the period from 0 to 1392 h)', 'unitOfMeasure': 'hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjects With AEs/SAEs Related to Eculizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': "The percentage of subjects with AEs/SAEs that, in the investigator's opinion, are related to eculizumab", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjects Who Develop Grade 3/4 AEs Related to Eculizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'OG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': "• The percentage of subjects with СТСАЕ v. 4.03 grade 3/4 AEs that, in the investigator's opinion, are related to eculizumab, by study arms.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BCD-148', 'description': '39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'FG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BCD-148', 'description': '39 healthy subjects BCD-148: single 900 mg drip infusion given over 25-45 min\n\nBCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'BG001', 'title': 'Soliris', 'description': '39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min\n\nSoliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '32'}, {'value': '27', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '32'}, {'value': '27', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '32'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-13', 'size': 887197, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-03T08:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-03', 'studyFirstSubmitDate': '2019-07-16', 'resultsFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2019-07-18', 'lastUpdatePostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-03', 'studyFirstPostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-∞ of Eculizumab', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'AUC0-∞ of eculizumab (the area under the Concentration vs. Time curve from 0 to infinity)'}], 'secondaryOutcomes': [{'measure': 'Cmax of Eculizumab', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Cmax of eculizumab (maximum concentration of eculizumab in the serum)'}, {'measure': 'Тmax of Eculizumab', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Тmax of eculizumab (time to Cmax)'}, {'measure': 'AUC0-1392 of Eculizumab', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'AUC0-1392 of eculizumab (the area under the Concentration vs. Time curve from 0 to 1392 h post-infusion)'}, {'measure': 'Т1/2 of Eculizumab', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Т1/2 of eculizumab (half-life)'}, {'measure': 'Vd of Eculizumab', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Vd of eculizumab (steady-state volume of distribution)'}, {'measure': 'Кel of Eculizumab', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Кel of eculizumab (elimination constant)'}, {'measure': 'Cl of Eculizumab', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Cl of eculizumab (clearance)'}, {'measure': 'ABEC(0-1392) CH50', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'ABEC(0-1392) CH50 (the area between the baseline and effect curves for hemolytic activity of serum complement from 0 to 1392 h)'}, {'measure': 'AUEC(0-1392) CH50', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'AUEC(0-1392) CH50 ((area under the Time vs. Effect curve from 0 to 1392 h)'}, {'measure': 'Emin CH50', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Emin CH50 (minimum hemolytic complement activity from 0 to 1392 h)'}, {'measure': 'Tmin CH50', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': 'Tmin CH50 (time to minimum hemolytic complement activity within the period from 0 to 1392 h)'}, {'measure': 'Subjects With AEs/SAEs Related to Eculizumab', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': "The percentage of subjects with AEs/SAEs that, in the investigator's opinion, are related to eculizumab"}, {'measure': 'Subjects Who Develop Grade 3/4 AEs Related to Eculizumab', 'timeFrame': 'from 0 to 1392 hours post-infusion', 'description': "• The percentage of subjects with СТСАЕ v. 4.03 grade 3/4 AEs that, in the investigator's opinion, are related to eculizumab, by study arms."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Healthy Volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed ICF for participation in the study\n2. Men from 18 to 45 years old (inclusive) at the time of signing the ICF\n3. BMI within the normal limits (18.0 to 30 kg/m2)\n4. The subject is able to follow the Protocol procedures (in the investigator\'s opinion)\n5. The subject is verified as "Healthy" according to results of standard clinical, laboratory and instrumental tests\n6. Normal hemodynamic parameters: systolic BP from 90 mmHg to 130 mmHg; diastolic BP from 60 mmHg to 90 mmHg; HR from 60 bpm to 90 bpm\n7. The subject and his sex partner of childbearing potential consent to implement reliable contraceptive methods from the moment the subject signs the ICF and until the subject completes the study. This requirement does not apply to those subjects who had undergone surgical sterilization. Reliable contraception methods mean one barrier method in combination with one of the following: spermicides, intrauterine device and/or oral contraceptives used by the subject\'s partner.\n8. The subject agrees not to drink alcohol for 24 h prior to the infusion of the test/reference drug and for the entire period while the subject is in the study.\n\n \\-\n\nExclusion Criteria:\n\n1. Psychiatric disorders or other conditions that can affect the ability of the subject to follow the study protocol\n2. Acute infections within 4 weeks before signing the ICF\n3. Results of laboratory and/or instrumental tests are outside the site\'s normal range\n4. Any surgery done within 30 days before the screening or planned within 30 days after the subject completes the study\n5. Impossibility to insert an intravenous catheter for blood collection (e.g., because of a skin condition at the venipuncture site)\n6. A history of allergies\n7. Known hypersensitivity to any component of BCD-148 or Soliris®, murine proteins or other drug components; hypersensitivity to any component of the meningococcal vaccine\n8. The subject had used any medications that significantly affect hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) within 30 days before signing the ICF and/or the subject needs any medications (other than the study drugs) to be taken during the entire study period\n9. The subject had previously used eculizumab and/or other therapeutic monoclonal antibodies against complement C5\n10. Regular use (oral or parenteral) of any drugs, including OTC products, vitamins or biologically active supplements within 14 calendar days before signing the ICF\n11. A history of recurrent/chronic hemorrhages or any hemorrhage within 30 days prior to signing the ICF\n12. Acute or chronic infections or other diseases that, in the investigator\'s opinion, may affect the PK, PD or safety of the study products\n13. HIV, HCV, HBV infection, syphilis.\n14. Meningococcal infection in the past (documented or mentioned verbally by the subject)\n15. Vaccination within 4 weeks before the planned infusion date, except for vaccination against Neisseria meningitidis given to all subjects in the screening period\n16. The subject refuses to get a vaccination against Neisseria meningitidis during the screening period .\n17. The subject smokes more than 10 cigarettes per day\n18. The subject consumes more than 10 units of alcohol per week (1 unit equals to 0.5 L of beer, 200 mL of wine or 50 mL of a strong alcohol beverage) or has a history of alcohol, recreational drug or medication abuse, or tests positive for alcohol and/or psychoactive substances during the screening examination\n19. Donation of ≥ 450 mL of blood or plasma within 60 calendar days before signing the ICF.\n20. Participation in any drug clinical studies within 30 calendar days prior to signing the informed consent form and through the entire period of study participation.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT04027803', 'briefTitle': 'Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocad'}, 'officialTitle': 'A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BCD-148-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BCD-148', 'description': '39 healthy subjects received BCD-148, 900 mg, a single drip infusion over 25-45 min', 'interventionNames': ['Biological: BCD-148']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Soliris', 'description': '39 healthy subjects received Soliris, 900 mg, a single drip infusion over 25-45 min', 'interventionNames': ['Biological: Soliris']}], 'interventions': [{'name': 'BCD-148', 'type': 'BIOLOGICAL', 'otherNames': ['eculizumab'], 'description': 'single intravenous infusion of BCD-148 (900 mg)', 'armGroupLabels': ['BCD-148']}, {'name': 'Soliris', 'type': 'BIOLOGICAL', 'otherNames': ['eculizumab'], 'description': 'single intravenous infusion of Soliris (900 mg)', 'armGroupLabels': ['Soliris']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Limited Liability Company Research Center Eco-Bezopasnost (OOO Research Center Eco-Bezopasnost)', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocad', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}