Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT05027451
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2021-08-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, and Pharmacokinetics of IXT-m200
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'misty.stevens@intervexion.com', 'phone': '501-554-2377', 'title': 'Chief Operating Officer', 'organization': 'InterveXion Therapeutics, LLC'}, 'certainAgreement': {'otherDetails': 'PI may prepare and submit manuscripts or slide shows based on Study Data. Such manuscripts or slide shows shall be submitted to Sponsor for review, at which time these may be approved or rejected. PI will not release those that are rejected by Sponsor. One investigator may be identified as an author or co-author of Sponsor-sponsored publications resulting from this study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected following the start of administration of study drug on Day 1 through the final study visit on Day 127.', 'description': 'AE data were collected at study visits or between visits if participants informed the site by phone or visit.', 'eventGroups': [{'id': 'EG000', 'title': 'IXT-m200', 'description': '3 g of IXT-m200 given once by 30-min intravenous infusion\n\nIXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SARS-CoV-2 antibody test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-related Adverse Events (AEs) Assessed by Physical Examinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IXT-m200', 'description': '3 g of IXT-m200 given once by 30-min intravenous infusion\n\nIXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '127 days', 'description': 'Physical examinations', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-related AEs Assessed by Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IXT-m200', 'description': '3 g of IXT-m200 given once by 30-min intravenous infusion\n\nIXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '127 days', 'description': 'Blood pressure, heart rate, and temperature', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-related AEs Assessed by ECG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IXT-m200', 'description': '3 g of IXT-m200 given once by 30-min intravenous infusion\n\nIXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 min post-dose completion', 'description': 'Electrocardiogram', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-related AEs Assessed by Clinical Laboratory Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IXT-m200', 'description': '3 g of IXT-m200 given once by 30-min intravenous infusion\n\nIXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '64 days', 'description': 'Clinical laboratory testing', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Time Course of IXT-m200 Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IXT-m200', 'description': '3 g of IXT-m200 given once by 30-min intravenous infusion\n\nIXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)'}], 'classes': [{'title': 'Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '1 hr post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '728', 'spread': '157', 'groupId': 'OG000'}]}]}, {'title': '4 hr post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '705', 'spread': '100', 'groupId': 'OG000'}]}]}, {'title': '8 hr post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '632', 'spread': '104', 'groupId': 'OG000'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '632', 'spread': '132', 'groupId': 'OG000'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '316', 'spread': '62.6', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '257', 'spread': '31', 'groupId': 'OG000'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '194', 'spread': '48', 'groupId': 'OG000'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '155', 'spread': '50.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '109', 'spread': '22.5', 'groupId': 'OG000'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.1', 'spread': '14.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.4', 'spread': '12.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.5', 'spread': '4.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 106', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.92', 'spread': '1.98', 'groupId': 'OG000'}]}]}, {'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.65', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '127 days', 'description': 'IXT-m200 concentrations over time', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving IXT-m200'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IXT-m200', 'description': '3 g of IXT-m200 given once by 30-min intravenous infusion\n\nIXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants underwent screening procedures to check eligibility criteria within 30 days prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IXT-m200', 'description': '3 g of IXT-m200 given once by 30-min intravenous infusion\n\nIXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Normal saline\n\nPlacebo: Normal saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'spread': '8.75', 'groupId': 'BG000'}, {'value': '42.5', 'spread': '13.44', 'groupId': 'BG001'}, {'value': '42.0', 'spread': '8.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'spread': '2.67', 'groupId': 'BG000'}, {'value': '24.38', 'spread': '4.91', 'groupId': 'BG001'}, {'value': '28.52', 'spread': '3.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '87.41', 'spread': '9.83', 'groupId': 'BG000'}, {'value': '64', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '82.21', 'spread': '13.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '171.5', 'spread': '5.91', 'groupId': 'BG000'}, {'value': '163', 'spread': '11.31', 'groupId': 'BG001'}, {'value': '169.59', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline assessments were conducted at the screening visit or on Day 1.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-25', 'size': 712000, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-28T15:50', 'hasProtocol': True}, {'date': '2021-12-15', 'size': 2499608, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-28T15:57', 'hasProtocol': False}, {'date': '2021-10-04', 'size': 420288, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-28T15:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-31', 'studyFirstSubmitDate': '2021-08-24', 'resultsFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2021-08-24', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-31', 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-related Adverse Events (AEs) Assessed by Physical Examinations', 'timeFrame': '127 days', 'description': 'Physical examinations'}, {'measure': 'Number of Participants With Treatment-related AEs Assessed by Vital Signs', 'timeFrame': '127 days', 'description': 'Blood pressure, heart rate, and temperature'}, {'measure': 'Number of Participants With Treatment-related AEs Assessed by ECG', 'timeFrame': '30 min post-dose completion', 'description': 'Electrocardiogram'}, {'measure': 'Number of Participants With Treatment-related AEs Assessed by Clinical Laboratory Testing', 'timeFrame': '64 days', 'description': 'Clinical laboratory testing'}], 'secondaryOutcomes': [{'measure': 'Time Course of IXT-m200 Concentrations', 'timeFrame': '127 days', 'description': 'IXT-m200 concentrations over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Approximately 9 participants will be enrolled in the study in a single cohort. Participants will be randomized to 3 g IXT-m200 or placebo at 7:2. Each will receive their dose as a 30-min intravenous infusion, then remain at the study site overnight to complete Day 1 and Day 2 assessments (e.g., electrocardiogram (ECG), laboratory assessments, blood draws, and vital signs). Following discharge on Day 2, participants will return to the clinic for follow-up pharmacokinetic (PK) and safety assessments on Day 8, then every 1-3 weeks thereafter until Day 127.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nEligible participants will:\n\n1. Be 18-65 years of age, inclusive, at the time of study consent;\n2. Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent;\n3. Be healthy, based on the pre-study medical evaluation (medical history and physical exam, vital signs, ECG, and clinical laboratory evaluations);\n4. Be willing to comply with study instructions and dosing, agree to make all appointments, and complete the entire course of the study;\n5. Be of nonchildbearing potential or agree to use protocol-specified method(s) of birth control throughout study participation;\n6. Agree to adhere to Lifestyle Considerations throughout study duration.\n\nExclusion Criteria:\n\n\\-\n\nEligible participants will NOT:\n\n1. Have a history of treatment with a monoclonal antibody in the past year;\n2. Have a known contraindication or sensitivity to IXT-m200 based on known allergies to other mAbs, any inactive ingredient of IXT-m200, or any other products required for the study procedures;\n3. Have a history of alcohol and/or drug use disorder, as determined by DSM-5 criteria;\n4. Have a history of stimulant use, including methamphetamine and amphetamine;\n5. Be currently taking certain other drugs and medications, including: "designer drugs" (e.g., 3,4-methylenedioxyMETH (MDMA, Ecstasy, Adam, XTC) and its N-dimethyl metabolite methylenedioxyamphetamine (MDA), anti-orexigenic drugs (including over-the-counter medications for weight loss), or be chronic users of phenethylamine compounds (e.g., phenylpropanolamine, ephedrine, pseudoephedrine, amphetamine, phentermine, phenmetrazine, methylphenidate, diethylpropion, and propylhexedrine);\n6. Have a positive drug screen for any psychoactive substances (legal or nonlegal) on Day 1 prior to dosing;\n7. Have a history of severe allergy (rash, hives, breathing difficulty, etc) to any medications;\n8. Have a history of allergic or environmental bronchial asthma within the past 3 years;\n9. Have a clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, gastrointestinal, cardiovascular, pulmonary (including chronic asthma), endocrine (eg, diabetes), central nervous (eg psychiatric conditions), or hematologic systems, or recent clinically significant surgery;\n10. Have a history of seizure, epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions;\n11. Have a planned or scheduled surgical procedure during the study;\n12. Have recently donated blood or plasma (within 30 days of study drug dose);\n13. Have a current diagnosis of anorexia nervosa or bulimia disorder;\n14. Be currently participating or has participated within the last 30 days prior to the start of this study in a drug, device, or other interventional research study;\n15. Be pregnant or lactating;\n16. In the Investigator\'s or Sponsor\'s (or designee) opinion, be inappropriate for the study.'}, 'identificationModule': {'nctId': 'NCT05027451', 'briefTitle': 'Safety, Tolerability, and Pharmacokinetics of IXT-m200', 'organization': {'class': 'INDUSTRY', 'fullName': 'InterveXion Therapeutics, LLC'}, 'officialTitle': 'A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single-Dose Intravenous Study to Evaluate the Safety and Pharmacokinetics of IXT-m200 in Healthy Participants', 'orgStudyIdInfo': {'id': 'M200C-2102'}, 'secondaryIdInfos': [{'id': 'U01DA045366', 'link': 'https://reporter.nih.gov/quickSearch/U01DA045366', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IXT-m200', 'description': '3 g of IXT-m200 given once by 30-min intravenous infusion', 'interventionNames': ['Drug: IXT-m200']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Normal saline', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'IXT-m200', 'type': 'DRUG', 'otherNames': ['ch-mAb7F9'], 'description': 'Anti-methamphetamine chimeric monoclonal antibody (mAb)', 'armGroupLabels': ['IXT-m200']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Normal saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07724', 'city': 'Eatontown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinilabs Drug Development Corporation', 'geoPoint': {'lat': 40.29622, 'lon': -74.05097}}], 'overallOfficials': [{'name': 'Chief Medical Officer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'InterveXion Therapeutics'}]}, 'ipdSharingStatementModule': {'timeFrame': 'These datasets will be available for distribution following submission to the FDA of the Clinical Study Report and publication. They will be available for 2 years after the initial publication.', 'ipdSharing': 'YES', 'description': 'Final datasets are expected to contain pharmacokinetic data on IXT-m200 and safety data. No individually identifiable private information will be distributed.', 'accessCriteria': 'These datasets and associated documentation will be made available on CD by the Sponsor to requestors under a data sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology and not distributing to third parties; and (3) a commitment to destroying or returning the data after analyses are completed. Requests should be sent to intervexion@gmail.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InterveXion Therapeutics, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}