Viewing Study NCT04971395

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Ignite Creation Date: 2025-12-24 @ 2:14 PM
Ignite Modification Date: 2025-12-27 @ 10:34 AM
Study NCT ID: NCT04971395
Status: COMPLETED
Last Update Posted: 2025-01-14
First Post: 2021-07-07
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tmatthews@xentria.com', 'phone': '224.443.4615', 'title': 'Tom Matthews, Director of Clinical Research', 'organization': 'Xentria, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.', 'eventGroups': [{'id': 'EG000', 'title': '2 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 2 mg/kg XTMAB-16', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '4 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 4 mg/kg XTMAB-16', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Pooled Placebo', 'description': 'Single IV Infusion of Placebo', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Pain due to Covid Testing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loose Stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foggy Feeling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participant With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 2 mg/kg XTMAB-16'}, {'id': 'OG001', 'title': '4 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 4 mg/kg XTMAB-16'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Single IV Infusion of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 71', 'description': 'Treatment-emergent adverse event, which is an undesirable event that occurs during or shortly after treatment begins.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 2 mg/kg XTMAB-16'}, {'id': 'OG001', 'title': '4 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 4 mg/kg XTMAB-16'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Single IV Infusion of Placebo'}], 'classes': [{'title': 'Day 1 ADA Screening', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 8 ADA Screening', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 15 ADA Screening', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 15 ADA Confirmatory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 29 ADA Screening', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 29 ADA Confirmatory', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 43 ADA Screening', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 43 ADA Confirmatory', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 57 ADA Screening', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 57 ADA Confirmatory', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 71 ADA Screening', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 71 ADA Confirmatory', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71', 'description': 'Participants by cohort who test positive for XTMAB-16 ADA', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 2 mg/kg XTMAB-16'}, {'id': 'OG001', 'title': '4 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 4 mg/kg XTMAB-16'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Single IV Infusion of Placebo'}], 'classes': [{'title': 'Day 29', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 43', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 57', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 71', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71', 'description': 'Participants by cohort who test positive for XTMAB-16 nAb', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'XTMAB-16 Maximum Observed Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 2 mg/kg XTMAB-16'}, {'id': 'OG001', 'title': '4 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 4 mg/kg XTMAB-16'}], 'classes': [{'categories': [{'measurements': [{'value': '64.17', 'spread': '9.94', 'groupId': 'OG000'}, {'value': '131', 'spread': '23.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 71', 'description': 'XTMAB-16 (Cmax)', 'unitOfMeasure': 'Cmax (μg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 2 mg/kg XTMAB-16'}, {'id': 'OG001', 'title': '4 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 4 mg/kg XTMAB-16'}], 'classes': [{'categories': [{'measurements': [{'value': '62.18', 'spread': '6.757', 'groupId': 'OG000'}, {'value': '128.9', 'spread': '22.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'XTMAB-16 serum (CT) Day 1', 'unitOfMeasure': 'CT (μg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Observed Concentration (Tmax) XTMAB-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 2 mg/kg XTMAB-16'}, {'id': 'OG001', 'title': '4 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 4 mg/kg XTMAB-16'}], 'classes': [{'categories': [{'measurements': [{'value': '2.16', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '8.65'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.12', 'upperLimit': '8.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71', 'description': 'Time to maximum observed concentration (tmax) XTMAB-16', 'unitOfMeasure': 'tmax (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the XTMAB-16 Concentration-time Curve From Time Zero (Predose) Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 2 mg/kg XTMAB-16'}, {'id': 'OG001', 'title': '4 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 4 mg/kg XTMAB-16'}], 'classes': [{'categories': [{'measurements': [{'value': '601.5', 'spread': '231.8', 'groupId': 'OG000'}, {'value': '1249', 'spread': '245.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71', 'description': 'Area under the XTMAB-16 concentration-time curve from time zero (predose) AUC0-∞', 'unitOfMeasure': 'AUC0-inf (day*μg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the XTMAB-16 Concentration-time-curve From Time Zero to (Predose) Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 2 mg/kg XTMAB-16'}, {'id': 'OG001', 'title': '4 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 4 mg/kg XTMAB-16'}], 'classes': [{'categories': [{'measurements': [{'value': '525.2', 'spread': '238.0', 'groupId': 'OG000'}, {'value': '1224', 'spread': '235.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71', 'description': 'Area under the XTMAB-16 concentration-time-curve from time zero to (predose) AUC0-t', 'unitOfMeasure': 'AUC0-last (day*μg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systemic Clearance After IV Dosing (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 2 mg/kg XTMAB-16'}, {'id': 'OG001', 'title': '4 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 4 mg/kg XTMAB-16'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2498', 'spread': '0.04883', 'groupId': 'OG000'}, {'value': '0.2449', 'spread': '0.06064', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 71', 'description': 'Systemic clearance after IV dosing (CL)', 'unitOfMeasure': 'CL (L/day)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Half-life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 2 mg/kg XTMAB-16'}, {'id': 'OG001', 'title': '4 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 4 mg/kg XTMAB-16'}], 'classes': [{'categories': [{'measurements': [{'value': '8.644', 'spread': '4.726', 'groupId': 'OG000'}, {'value': '10.23', 'spread': '3.617', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 71', 'unitOfMeasure': 't1/2 (day)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution Following IV Dosing (Vz) Day 1 up to Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 2 mg/kg XTMAB-16'}, {'id': 'OG001', 'title': '4 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 4 mg/kg XTMAB-16'}], 'classes': [{'categories': [{'measurements': [{'value': '2.864', 'spread': '0.8861', 'groupId': 'OG000'}, {'value': '3.435', 'spread': '0.9878', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 71', 'unitOfMeasure': 'Vz (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Residence Time (MRT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 2 mg/kg XTMAB-16'}, {'id': 'OG001', 'title': '4 mg/kg XTMAB-16', 'description': 'Single IV Infusion of 4 mg/kg XTMAB-16'}], 'classes': [{'categories': [{'measurements': [{'value': '12.51', 'spread': '6.214', 'groupId': 'OG000'}, {'value': '13.32', 'spread': '3.794', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 71', 'description': 'Mean residence time (MRT)', 'unitOfMeasure': 'MRT (day)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pooled Placebo', 'description': 'Participants received a single IV Infusion of Placebo'}, {'id': 'FG001', 'title': 'Single IV Infusion of 2 mg/kg of XTMAB-16', 'description': 'Participants received a single dose of 2 mg/kg of XTMAB-16'}, {'id': 'FG002', 'title': 'Single IV Infusion of 4 mg/kg of XTMAB-16', 'description': 'Participants received a single dose of 4 mg/kg of XTMAB-16'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 24 normal healthy adult participants were planned to be enrolled and assigned into 2 treatment cohorts with 12 participants (9 on XTMAB-16 and 3 on placebo). Participants received a single IV infusion of 2 or 4 mg/kg of study drug (XTMAB-16 or placebo) on Day 1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Single IV Infusion of 2 mg/kg of XTMAB-16', 'description': 'Participants received a single dose of 2 mg/kg XTMAB-16'}, {'id': 'BG001', 'title': 'Single IV Infusion of 4 mg/kg of XTMAB-16', 'description': 'Participants received a single dose of 4 mg/kg XTMAB-16'}, {'id': 'BG002', 'title': 'Pooled Placebo', 'description': 'Participants received a single IV Infusion of Placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-28', 'size': 4760773, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-23T17:26', 'hasProtocol': True}, {'date': '2022-03-22', 'size': 3083611, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-23T17:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2021-07-07', 'resultsFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-03', 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to day 71', 'description': 'Treatment-emergent adverse event, which is an undesirable event that occurs during or shortly after treatment begins.'}], 'secondaryOutcomes': [{'measure': 'Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)', 'timeFrame': 'ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71', 'description': 'Participants by cohort who test positive for XTMAB-16 ADA'}, {'measure': 'Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb)', 'timeFrame': 'ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71', 'description': 'Participants by cohort who test positive for XTMAB-16 nAb'}, {'measure': 'XTMAB-16 Maximum Observed Concentration (Cmax)', 'timeFrame': 'Up to day 71', 'description': 'XTMAB-16 (Cmax)'}, {'measure': 'XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1', 'timeFrame': 'Day 1', 'description': 'XTMAB-16 serum (CT) Day 1'}, {'measure': 'Time to Maximum Observed Concentration (Tmax) XTMAB-16', 'timeFrame': 'PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71', 'description': 'Time to maximum observed concentration (tmax) XTMAB-16'}, {'measure': 'Area Under the XTMAB-16 Concentration-time Curve From Time Zero (Predose) Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞)', 'timeFrame': 'PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71', 'description': 'Area under the XTMAB-16 concentration-time curve from time zero (predose) AUC0-∞'}, {'measure': 'Area Under the XTMAB-16 Concentration-time-curve From Time Zero to (Predose) Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)', 'timeFrame': 'PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71', 'description': 'Area under the XTMAB-16 concentration-time-curve from time zero to (predose) AUC0-t'}, {'measure': 'Systemic Clearance After IV Dosing (CL)', 'timeFrame': 'Up to day 71', 'description': 'Systemic clearance after IV dosing (CL)'}, {'measure': 'Apparent Terminal Half-life (t1/2)', 'timeFrame': 'Up to day 71'}, {'measure': 'Volume of Distribution Following IV Dosing (Vz) Day 1 up to Day 71', 'timeFrame': 'Up to day 71'}, {'measure': 'Mean Residence Time (MRT)', 'timeFrame': 'Up to day 71', 'description': 'Mean residence time (MRT)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized, double-blind, placebo-controlled, first-in-human, single intravenous (IV) infusion of XTMAB-16 (formerly referred to as KBMAB-16) in normal healthy male and female participants.', 'detailedDescription': 'A total of 24 normal healthy adult participants will be enrolled and assigned into 2 treatment cohorts with 12 participants (9 on XTMAB-16 and 3 on placebo) in each cohort. Participants will receive a single IV infusion of 2 mg/kg or 4 mg/kg of XTMAB-16 or placebo on Day 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* The participant is a healthy adult male or female aged 18 to 45 years, inclusive, at the time of informed consent.\n* The participant weighs between 45 kg (99 lbs) and 100 kg (220 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at the time of informed consent.\n* The participant agrees to use highly effective method of contraception from the time of signing consent throughout 90 days after dosing.\n\nKey Exclusion Criteria:\n\n* The participant has received any investigational compound within 90 days before dosing.\n* The participant has any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease or disorder, or other abnormality, which may affect the participant's safety, increase risk of seizure or lower the seizure threshold, or potentially confound the study results. It is the responsibility of the Investigator to assess the clinical significance of any conditions the participant may have; however, consultation with the Xentria Medical Monitor may be warranted.\n* The participant has a known hypersensitivity to any component of the formulation of XTMAB-16.\n* The participant has a positive result for drugs of abuse (defined as any illicit drug use) or alcohol at Screening or Baseline (Day -2).\n* The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to Screening or is unwilling to agree to abstain from alcohol and drugs throughout the study."}, 'identificationModule': {'nctId': 'NCT04971395', 'briefTitle': 'Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xentria, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants', 'orgStudyIdInfo': {'id': 'XTMAB-16-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single IV Infusion', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'XTMAB-16 2mg/kg', 'description': 'Single IV Infusion', 'interventionNames': ['Drug: XTMAB-16 2 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'XTMAB-16 4mg/kg', 'description': 'Single IV Infusion', 'interventionNames': ['Drug: XTMAB-16 4mg/kg']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Single dose of 2 or 4 mg/kg', 'armGroupLabels': ['Placebo']}, {'name': 'XTMAB-16 2 mg/kg', 'type': 'DRUG', 'description': 'Single dose of 2 mg/kg', 'armGroupLabels': ['XTMAB-16 2mg/kg']}, {'name': 'XTMAB-16 4mg/kg', 'type': 'DRUG', 'description': 'Single dose of 4 mg/kg', 'armGroupLabels': ['XTMAB-16 4mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Harbor Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Ray Goldwater, MDCM, M.Sc(A), CPI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Parexel Baltimore Early Phase Clinical Unit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xentria, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}