Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-28 @ 1:29 PM
Study NCT ID:
NCT03693950
Status:
COMPLETED
Last Update Posted:
2020-04-21
First Post:
2018-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'linkova@biocad.ru', 'phone': '+7 (495) 992 66 28 ext. 930', 'title': 'Yulia Linkova Medical Director', 'organization': 'BIOCAD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)', 'eventGroups': [{'id': 'EG000', 'title': 'BCD-066 1 µg/kg', 'description': 'Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nBCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 5, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aranesp 1 µg/kg', 'description': 'Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nAranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 16, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'monocytes count increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thrombocytes count increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematocrit decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoglobin decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WBC decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophis count decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RBC decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC(0-72)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-066 1 µg/kg', 'description': 'Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nBCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg'}, {'id': 'OG001', 'title': 'Aranesp 1 µg/kg', 'description': 'Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nAranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '328215.65', 'groupId': 'OG000', 'lowerLimit': '275530.49', 'upperLimit': '401053.38'}, {'value': '290827.12', 'groupId': 'OG001', 'lowerLimit': '252607.47', 'upperLimit': '349760.35'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose', 'description': 'The area concentration curve for darbepoetin alfa from injection to 72 h (AUC(0-72) after the first and the fourth IV injection of BCD-066 or Aranesp', 'unitOfMeasure': 'pg/ml·h', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-066 1 µg/kg', 'description': 'Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nBCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg'}, {'id': 'OG001', 'title': 'Aranesp 1 µg/kg', 'description': 'Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nAranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '18365.15', 'groupId': 'OG000', 'lowerLimit': '16861.5', 'upperLimit': '22490'}, {'value': '17003.25', 'groupId': 'OG001', 'lowerLimit': '13716.6', 'upperLimit': '19664.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose post-dose', 'description': 'The maximum concentration of darbepoetin alfa in the serum after the first and the fourth IV injection of BCD-066 or Aranesp®', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'T½', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-066 1 µg/kg', 'description': 'Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nBCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg'}, {'id': 'OG001', 'title': 'Aranesp 1 µg/kg', 'description': 'Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nAranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '12.53', 'groupId': 'OG000', 'lowerLimit': '11.334', 'upperLimit': '13.235'}, {'value': '12.69', 'groupId': 'OG001', 'lowerLimit': '11.47', 'upperLimit': '13.555'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose', 'description': 'The elimination half-life', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC(0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-066 1 µg/kg', 'description': 'Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nBCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg'}, {'id': 'OG001', 'title': 'Aranesp 1 µg/kg', 'description': 'Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nAranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '331725.75', 'groupId': 'OG000', 'lowerLimit': '276986.83', 'upperLimit': '404075.52'}, {'value': '296135.38', 'groupId': 'OG001', 'lowerLimit': '260610.81', 'upperLimit': '356012.29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose', 'description': 'The total area under the concentration curve from 0 to infinity', 'unitOfMeasure': 'pg/ml·h', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-066 1 µg/kg', 'description': 'Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nBCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg'}, {'id': 'OG001', 'title': 'Aranesp 1 µg/kg', 'description': 'Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nAranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.125', 'groupId': 'OG000', 'lowerLimit': '0.083', 'upperLimit': '0.25'}, {'value': '0.083', 'groupId': 'OG001', 'lowerLimit': '0.083', 'upperLimit': '0.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose', 'description': 'The time to maximum drug concentration in the serum', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Kel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-066 1 µg/kg', 'description': 'Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nBCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg'}, {'id': 'OG001', 'title': 'Aranesp 1 µg/kg', 'description': 'Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nAranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.055', 'groupId': 'OG000', 'lowerLimit': '0.052', 'upperLimit': '0.06'}, {'value': '0.055', 'groupId': 'OG001', 'lowerLimit': '0.051', 'upperLimit': '0.06'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose', 'description': 'The elimination constant: kel=1/MRT, where MRT is median residence time: MRT=AUMC(0-72)/AUC(0-72)', 'unitOfMeasure': 'fraction of drug per hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-066 1 µg/kg', 'description': 'Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nBCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg'}, {'id': 'OG001', 'title': 'Aranesp 1 µg/kg', 'description': 'Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nAranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '230.358', 'groupId': 'OG000', 'lowerLimit': '210.737', 'upperLimit': '275.827'}, {'value': '243.055', 'groupId': 'OG001', 'lowerLimit': '197.849', 'upperLimit': '299.107'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose', 'description': 'The total clearance', 'unitOfMeasure': 'ml/h', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BCD-066 1 µg/kg', 'description': 'Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nBCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg'}, {'id': 'FG001', 'title': 'Aranesp 1 µg/kg', 'description': 'Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nAranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BCD-066 1 µg/kg', 'description': 'Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nBCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg'}, {'id': 'BG001', 'title': 'Aranesp 1 µg/kg', 'description': 'Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.\n\nAranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '31'}, {'value': '27.50', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '31'}, {'value': '27.50', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '31'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'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': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-02', 'size': 263418, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-01T16:52', 'hasProtocol': False}, {'date': '2016-10-02', 'size': 269597, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-08T06:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-08', 'studyFirstSubmitDate': '2018-10-01', 'resultsFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2018-10-01', 'lastUpdatePostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-08', 'studyFirstPostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(0-72)', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose', 'description': 'The area concentration curve for darbepoetin alfa from injection to 72 h (AUC(0-72) after the first and the fourth IV injection of BCD-066 or Aranesp'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose post-dose', 'description': 'The maximum concentration of darbepoetin alfa in the serum after the first and the fourth IV injection of BCD-066 or Aranesp®'}, {'measure': 'T½', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose', 'description': 'The elimination half-life'}, {'measure': 'AUC(0-∞)', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose', 'description': 'The total area under the concentration curve from 0 to infinity'}, {'measure': 'Tmax', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose', 'description': 'The time to maximum drug concentration in the serum'}, {'measure': 'Kel', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose', 'description': 'The elimination constant: kel=1/MRT, where MRT is median residence time: MRT=AUMC(0-72)/AUC(0-72)'}, {'measure': 'CL', 'timeFrame': '5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose', 'description': 'The total clearance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'BCD-066 is a darbepoetin alfa. Clinical study BCD-066-3 is a double-blind controlled, randomized, parallel-group study of the pharmacokinetics, pharmacodynamics, tolerability, and safety of multiple intravenous injections of BCD-066 and Aranesp®.\n\nThe purpose of the study is to confirm the equivalent pharmacokinetics, pharmacodynamics, safety, and tolerability of multiple IV injections of BCD-066 and Aranesp® in healthy volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent form\n2. Men from 18 to 45 years old (inclusive)\n3. BMI within the normal limits (18.5 to 30 kg/m2)\n4. Hemoglobin from 120 g/L to 150 g/L and hematocrit 41% to 49% at screening (before the first injection)\n5. Serum transferring 2.15 g/L to 3.6 g/L; serum ferritin from 20 μg/L to 250 μg/L\n6. Vitamin B12 from 187 pcg/mL to 883 pcg/mL; folic acid from 3.1 ng/mL to 20.5 ng/mL\n7. Endogenous serum erythropoietin \\< 30 mIU/mL at screening\n8. The subject is verified as "Healthy" according to results of standard clinical, laboratory and instrumental tests\n9. Subject\'s ability (in the investigator\'s opinion) to follow the protocol procedures\n10. The subject and his sexual partner with retained childbearing potential consent to implement reliable contraceptive methods starting 2 weeks before inclusion in the study and up to 2 weeks after the last dose of the test/reference drug. This requirement does not apply to surgically sterile subjects. 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.\n11. The subject agrees not to drink alcohol for 24 h prior to each injection of the test/reference drug and for 72 h after the injection.\n\nExclusion Criteria:\n\n1\\. Psychiatric disorders or other conditions that can affect the ability of the subject to follow the study protocol 2. Acute infections within 4 weeks before the study start 3. Results of laboratory and/or instrumental tests are outside the normal range 4. Chronic cardiovascular, bronchial and/or pulmonary, neuroendocrine GI, liver, kidney, and blood diseases, including ischemic heart disease, arterial hypertension, peripheral vascular and/or cerebral vascular disorders, and thrombocytosis 5. A history of chronic hemorrhages\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03693950', 'briefTitle': 'The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocad'}, 'officialTitle': 'A Double-blind, Randomized, Controlled Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, and Safety of Multiple Intravenous Injections of BCD-066 and Aranesp® in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BCD-066-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BCD-066 1 µg/kg', 'description': 'Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.', 'interventionNames': ['Biological: BCD-066']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aranesp 1 µg/kg', 'description': 'Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.', 'interventionNames': ['Biological: Aranesp']}], 'interventions': [{'name': 'BCD-066', 'type': 'BIOLOGICAL', 'otherNames': ['darbepoetin alfa'], 'description': 'BCD-066 will be administered once a week intravenously in a dose 1 µg/kg', 'armGroupLabels': ['BCD-066 1 µg/kg']}, {'name': 'Aranesp', 'type': 'BIOLOGICAL', 'otherNames': ['darbepoetin alfa'], 'description': 'Aranesp will be administered once a week intravenously in a dose 1 µg/kg', 'armGroupLabels': ['Aranesp 1 µg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '198515', 'city': 'Saint Petersburg', 'state': 'Strelna', 'country': 'Russia', 'facility': 'BIOCAD', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Roman Ivanov, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'JCS BIOCAD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocad', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}