Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-06 @ 8:06 AM
Study NCT ID:
NCT03123094
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2017-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single Rising Dose Trial of Spesolimab (BI 655130) for Healthy Japanese Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712973', 'term': 'spesolimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Centre', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until the end of trial examination, up to 151 days.', 'description': 'Treated set (TS): TS includes all subjects dispensed trial medication and documented to have taken at least one dose of investigational treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Spesolimab Low Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Spesolimab Medium Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Spesolimab High Dose Group', 'description': 'Subjects administered single dose of 1200 mg BI 655130 solution for infusion as intravenous as 90 min infusion on day 1 visit 2.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Spesolimab Low Dose Group (Subcutaneous)', 'description': 'Subjects were administered a single dose of solution for injection of spesolimab in the range of 300-1200 milligrams (mg) as subcutaneous injection on day 1 of visit 2.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo Matching to Spesolimab', 'description': 'Subjects administered placebo matching to spesolimab solution for infusion as intravenous as 90 min infusion or subcutaneous injection on day 1 of visit 2.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Temporomandibular joint syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Drug-related Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Spesolimab Low Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'OG001', 'title': 'Spesolimab Medium Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'OG002', 'title': 'Spesolimab High Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'OG003', 'title': 'Spesolimab Low Dose Group (Subcutaneous)', 'description': 'Subjects were administered a single dose of solution for injection of spesolimab in the range of 300-1200 milligrams (mg) as subcutaneous injection on day 1 of visit 2.'}, {'id': 'OG004', 'title': 'Placebo Matching to Spesolimab', 'description': 'Subjects administered placebo matching to spesolimab solution for infusion as intravenous as 90 min infusion or subcutaneous injection on day 1 of visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first drug administration until the end of trial examination, up to 151 days.', 'description': 'The primary endpoint is to assess safety and tolerability of spesolimab as the number \\[N\\] of subjects with drug-related AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): TS includes all subjects dispensed trial medication and documented to have taken at least one dose of investigational treatment.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of Spesolimab in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Spesolimab Low Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'OG001', 'title': 'Spesolimab Medium Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'OG002', 'title': 'Spesolimab High Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'OG003', 'title': 'Spesolimab Low Dose Group (Subcutaneous)', 'description': 'Subjects were administered a single dose of solution for injection of spesolimab in the range of 300-1200 milligrams (mg) as subcutaneous injection on day 1 of visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '1890', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '3930', 'spread': '18.4', 'groupId': 'OG001'}, {'value': '7060', 'spread': '18.0', 'groupId': 'OG002'}, {'value': '1390', 'spread': '24.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9533', 'ciLowerLimit': '0.7810', 'ciUpperLimit': '1.1256', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0803', 'estimateComment': 'Standard error of mean is actually standard error of slope.', 'groupDescription': 'Dose proportionality was explored using the power model. Dose proportionality of spesolimab was to be assessed based on the exposure parameter AUC0-∞, determined for the 3 intravenous dose levels (perfect dose proportionality would correspond to a slope of 1).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to 3528 hours after administration of spesolimab.', 'description': 'AUC0-∞, Area under the concentration-time curve of spesolimab in plasma over the time interval from 0 extrapolated to infinity is presented.\n\nPharmacokinetic samples were collected within 2 hours pre-dose and at 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 hours after dosing of dose groups with intravenous administration of spesolimab.\n\nPharmacokinetic samples were collected within 2 hours pre-dose and at 0.5, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 hours after dosing of dose groups with subcutaneous administration of spesolimab.', 'unitOfMeasure': 'Day*microgram/millilitre [day∙μg/mL]', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set (PKS): PKS includes all subjects in the treated set who provided at least one PK parameter not excluded due to a protocol violation relevant to the evaluation of PK. Only participants with evaluable results for this PK parameter are reported.'}, {'type': 'SECONDARY', 'title': 'Maximum Measured Concentration of Spesolimab in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Spesolimab Low Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'OG001', 'title': 'Spesolimab Medium Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'OG002', 'title': 'Spesolimab High Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'OG003', 'title': 'Spesolimab Low Dose Group (Subcutaneous)', 'description': 'Subjects were administered a single dose of solution for injection of spesolimab in the range of 300-1200 milligrams (mg) as subcutaneous injection on day 1 of visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.7', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '193.0', 'spread': '17.9', 'groupId': 'OG001'}, {'value': '400.0', 'spread': '12.9', 'groupId': 'OG002'}, {'value': '32.2', 'spread': '21.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0014', 'ciLowerLimit': '0.8809', 'ciUpperLimit': '1.1219', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0568', 'estimateComment': 'Standard error of mean is actually standard error of slope.', 'groupDescription': 'Dose proportionality was explored using the power model. Dose proportionality of spesolimab was to be assessed based on the exposure parameter Cmax, determined for the 3 intravenous dose levels (perfect dose proportionality would correspond to a slope of 1).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to 3528 hours after administration of spesolimab.', 'description': 'Cmax, maximum measured concentration of spesolimab in plasma is presented. Pharmacokinetic samples were collected within 2 hours pre-dose and at 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 hours after dosing of dose groups with intravenous administration of Up to 3528 hours after administration of spesolimab.\n\nPharmacokinetic samples were collected within 2 hours pre-dose and at 0.5, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 hours after dosing of dose groups with subcutaneous administration of spesolimab.', 'unitOfMeasure': 'Microgram/millilitre [μg/mL]', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set (PKS): PKS includes all subjects in the treated set who provided at least one PK parameter not excluded due to a protocol violation relevant to the evaluation of PK.'}, {'type': 'SECONDARY', 'title': 'Total Clearance of Spesolimab in Plasma After Intravenous Administration (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Spesolimab Low Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'OG001', 'title': 'Spesolimab Medium Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'OG002', 'title': 'Spesolimab High Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.159', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '0.153', 'spread': '18.4', 'groupId': 'OG001'}, {'value': '0.170', 'spread': '18.0', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pharmacokinetic samples were collected within 2 hours (h) pre-dose and at 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 h after dosing of dose groups with intravenous administration of spesolimab.', 'description': 'CL, total clearance of spesolimab in plasma after intravenous administration is presented for intravenous dose groups.', 'unitOfMeasure': 'Litre/day [L/day]', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set (PKS): PKS includes all subjects in the treated set who provided at least one PK parameter not excluded due to a protocol violation relevant to the evaluation of PK. Only participants with evaluable results for this PK parameter are reported.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady State After Intravenous Administration of Spesolimab (Vss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Spesolimab Low Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'OG001', 'title': 'Spesolimab Medium Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'OG002', 'title': 'Spesolimab High Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.19', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '6.97', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '6.60', 'spread': '11.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pharmacokinetic samples were collected within 2 hours (h) pre-dose and at 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 h after dosing of dose groups with intravenous administration of spesolimab.', 'description': 'Vss, volume of distribution at steady state after intravenous administration of spesolimab is presented for intravenous dose groups.', 'unitOfMeasure': 'Litre [L]', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set (PKS): PKS includes all subjects in the treated set who provided at least one PK parameter not excluded due to a protocol violation relevant to the evaluation of PK. Only participants with evaluable results for this PK parameter are reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spesolimab Low Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'FG001', 'title': 'Spesolimab Medium Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'FG002', 'title': 'Spesolimab High Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'FG003', 'title': 'Spesolimab Low Dose Group (Subcutaneous)', 'description': 'Subjects were administered a single dose of solution for injection of spesolimab in the range of 300-1200 milligrams (mg) as subcutaneous injection on day 1 of visit 2.'}, {'id': 'FG004', 'title': 'Placebo Matching to Spesolimab', 'description': 'Subjects administered placebo matching to spesolimab solution for infusion as intravenous as 90 min infusion or subcutaneous injection on day 1 of visit 2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This was a double-blind, randomised, and placebo-controlled trial of single rising intravenous (IV) doses and single subcutaneous (SC) doses of spesolimab (BI 655130) in healthy male Japanese subjects.', 'preAssignmentDetails': 'All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were not met.\n\nDose level for each arm cannot be provided because the information is a combination of both commercially sensitive confidential information as well as proprietary information.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Spesolimab Low Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'BG001', 'title': 'Spesolimab Medium Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'BG002', 'title': 'Spesolimab High Dose Group (Intravenous)', 'description': 'Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2.'}, {'id': 'BG003', 'title': 'Spesolimab Low Dose Group (Subcutaneous)', 'description': 'Subjects were administered a single dose of solution for injection of spesolimab in the range of 300-1200 milligrams (mg) as subcutaneous injection on day 1 of visit 2.'}, {'id': 'BG004', 'title': 'Placebo Matching to Spesolimab', 'description': 'Subjects administered placebo matching to spesolimab solution for infusion as intravenous as 90 min infusion or subcutaneous injection on day 1 of visit 2.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'spread': '4.51', 'groupId': 'BG000'}, {'value': '31.5', 'spread': '4.85', 'groupId': 'BG001'}, {'value': '36.7', 'spread': '3.56', 'groupId': 'BG002'}, {'value': '34.7', 'spread': '5.24', 'groupId': 'BG003'}, {'value': '31.4', 'spread': '7.65', 'groupId': 'BG004'}, {'value': '33.0', 'spread': '5.61', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS): TS includes all subjects dispensed trial medication and documented to have taken at least one dose of investigational treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-01', 'size': 693434, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-02T03:55', 'hasProtocol': True}, {'date': '2018-02-01', 'size': 250998, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-02T03:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2017-04-13', 'resultsFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2017-04-18', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-11', 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Drug-related Adverse Events (AEs)', 'timeFrame': 'From first drug administration until the end of trial examination, up to 151 days.', 'description': 'The primary endpoint is to assess safety and tolerability of spesolimab as the number \\[N\\] of subjects with drug-related AEs.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of Spesolimab in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'timeFrame': 'Up to 3528 hours after administration of spesolimab.', 'description': 'AUC0-∞, Area under the concentration-time curve of spesolimab in plasma over the time interval from 0 extrapolated to infinity is presented.\n\nPharmacokinetic samples were collected within 2 hours pre-dose and at 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 hours after dosing of dose groups with intravenous administration of spesolimab.\n\nPharmacokinetic samples were collected within 2 hours pre-dose and at 0.5, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 hours after dosing of dose groups with subcutaneous administration of spesolimab.'}, {'measure': 'Maximum Measured Concentration of Spesolimab in Plasma (Cmax)', 'timeFrame': 'Up to 3528 hours after administration of spesolimab.', 'description': 'Cmax, maximum measured concentration of spesolimab in plasma is presented. Pharmacokinetic samples were collected within 2 hours pre-dose and at 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 hours after dosing of dose groups with intravenous administration of Up to 3528 hours after administration of spesolimab.\n\nPharmacokinetic samples were collected within 2 hours pre-dose and at 0.5, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 hours after dosing of dose groups with subcutaneous administration of spesolimab.'}, {'measure': 'Total Clearance of Spesolimab in Plasma After Intravenous Administration (CL)', 'timeFrame': 'Pharmacokinetic samples were collected within 2 hours (h) pre-dose and at 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 h after dosing of dose groups with intravenous administration of spesolimab.', 'description': 'CL, total clearance of spesolimab in plasma after intravenous administration is presented for intravenous dose groups.'}, {'measure': 'Volume of Distribution at Steady State After Intravenous Administration of Spesolimab (Vss)', 'timeFrame': 'Pharmacokinetic samples were collected within 2 hours (h) pre-dose and at 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 h after dosing of dose groups with intravenous administration of spesolimab.', 'description': 'Vss, volume of distribution at steady state after intravenous administration of spesolimab is presented for intravenous dose groups.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '36451029', 'type': 'DERIVED', 'citation': 'Joseph D, Thoma C, Haeufel T, Li X. Assessment of the Pharmacokinetics and Safety of Spesolimab, a Humanised Anti-interleukin-36 Receptor Monoclonal Antibody, in Healthy Non-Japanese and Japanese Subjects: Results from Phase I Clinical Studies. Clin Pharmacokinet. 2022 Dec;61(12):1771-1787. doi: 10.1007/s40262-022-01176-5. Epub 2022 Dec 1.'}], 'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to investigate the safety and tolerability of spesolimab following administration of single rising intravenous doses and single subcutaneous dose in healthy Japanese male volunteers.\n\nSecondary objective is the exploration of the pharmacokinetics including dose proportionality of spesolimab in healthy Japanese male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure \\[BP\\], Pulse Rate \\[PR\\]), 12-lead Electrocardiogram \\[ECG\\], and clinical laboratory tests.\n* Japanese ethnicity, according to the following criteria:\n\n \\-- born in Japan, have lived outside of Japan \\<10 years, and have parents and grandparents who were all born in Japan\n* Age of 20 to 45 years (incl.)\n* Body Mass Index \\[BMI\\] of 18.5 to 25.0 kg/m2 (incl.)\n* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation\n* Male subjects who agree to minimize the risk of female partners being pregnant by fulfilling any of the following criteria starting from the first administration of trial medication and until 30 days after trial completion:\n\n * Use of adequate contraception, e.g. any of the following methods plus condom:\n\ncombined oral contraceptives, intrauterine device\n\n* A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)\n* Surgically sterilised (including hysterectomy) female partner\n\nExclusion Criteria:\n\n* Any finding in the medical examination (including Blood Pressure \\[BP\\], Pulse Rate \\[PR\\] or Electrocardiogram \\[ECG\\]) is deviating from normal and judged as clinically relevant by the investigator\n* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm\n* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n* Any evidence of a concomitant disease judged as clinically relevant by the investigator\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders\n* History of relevant orthostatic hypotension, fainting spells, or blackouts\n* Chronic or relevant acute infections including active tuberculosis, HIV or viral hepatitis; QuantiFERON TB test will be performed at screening.\n* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)\n* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)\n* Participation in another trial where an investigational drug has been administered within 5 half-lives prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug.\n* Administered live vaccine within 6 weeks prior to randomisation or Have plans for administration of live vaccines during the study period.\n* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)\n* Inability to refrain from smoking on specified trial days\n* Alcohol abuse (consumption of more than 30 g per day)\n* Drug abuse or positive drug screening\n* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial\n* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial\n* Inability to comply with dietary regimen of trial site\n* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males) or any other relevant Electrocardiogram \\[ECG\\] finding at screening\n* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)\n* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study\n* Further exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT03123094', 'briefTitle': 'Single Rising Dose Trial of Spesolimab (BI 655130) for Healthy Japanese Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Dose and Single Subcutaneous Dose of BI 655130 in Healthy Japanese Male Volunteers (Double-blind, Randomised, Placebo-controlled Design).', 'orgStudyIdInfo': {'id': '1368-0009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spesolimab low dose group (intravenous)', 'interventionNames': ['Drug: Spesolimab']}, {'type': 'EXPERIMENTAL', 'label': 'Spesolimab medium dose group (intravenous)', 'interventionNames': ['Drug: Spesolimab']}, {'type': 'EXPERIMENTAL', 'label': 'Spesolimab high dose group (intravenous)', 'interventionNames': ['Drug: Spesolimab']}, {'type': 'EXPERIMENTAL', 'label': 'Spesolimab low dose group (subcutaneous)', 'interventionNames': ['Drug: Spesolimab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo matching to spesolimab', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Spesolimab', 'type': 'DRUG', 'otherNames': ['BI 655130'], 'description': 'single dose', 'armGroupLabels': ['Spesolimab high dose group (intravenous)', 'Spesolimab low dose group (intravenous)', 'Spesolimab low dose group (subcutaneous)', 'Spesolimab medium dose group (intravenous)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'single dose', 'armGroupLabels': ['Placebo matching to spesolimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47392', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to:\n\nhttps://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}