Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-03-15 @ 12:37 PM
Study NCT ID:
NCT03055403
Status:
COMPLETED
Last Update Posted:
2021-11-30
First Post:
2017-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-28', 'studyFirstSubmitDate': '2017-02-10', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events as a measure of safety and tolerability', 'timeFrame': 'Throughout the study duration (up to day8)', 'description': 'adverse events, serious adverse events, physical examinations, vital sign measurements, 12-lead ECGs, Holter ECG, clinical laboratory safety tests (including hematology, chemistry, and urinalysis), recording of concomitant medications and procedures.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics-Cmax', 'timeFrame': 'Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A', 'description': 'Observed maximum plasma concentration (Cmax) of M201-A'}, {'measure': 'Pharmacokinetics-Tmax', 'timeFrame': 'Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A', 'description': 'Time to Cmax (Tmax) of M201-A'}, {'measure': 'Pharmacokinetics-AUC0-24', 'timeFrame': 'Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A', 'description': 'Area under the plasma concentration-time curve from time zero to 24hour of M201-A'}, {'measure': 'Pharmacokinetics-AUC0-t', 'timeFrame': 'Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A', 'description': '-Area under the plasma concentration-time curve calculated from time zero to the last measured time point (AUC0-t) of M201-A'}, {'measure': 'Pharmacokinetics-AUC0-∞', 'timeFrame': 'Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A', 'description': 'Area under the plasma concentration-time curve calculated from time zero to infinity (AUC0-∞) of M201-A'}, {'measure': 'Pharmacokinetics-t1/2', 'timeFrame': 'Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A', 'description': 'Elimination half-life (t1/2) of M201-A'}, {'measure': 'Pharmacokinetics-CL', 'timeFrame': 'Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A', 'description': 'Apparent clearance of drug from plasma (CL) of M201-A'}, {'measure': 'Pharmacokinetics-Vd', 'timeFrame': 'Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A', 'description': 'Apparent volume of distribution during the terminal phase (Vd) of M201-A'}, {'measure': 'Pharmacokinetics-E0-24', 'timeFrame': 'up to 24 hours', 'description': 'Amount of drug excreted in urine from time zero to 24hour of M201-A'}, {'measure': 'Pharmacokinetics-Ae', 'timeFrame': 'up to 24 hours', 'description': 'Urinary excretion rate of M201-A'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single continuous intravenous injection in Healthy Japanese subjects.', 'detailedDescription': 'Not Provided'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must satisfy the following criteria to be enrolled in the study:\n\n* Japanese Healthy Male subjects\n* Age 20 to less than 40 years of age\n* Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2\n* Written informed consent must be obtained on a voluntary basis before any assessment is performed.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a subject from enrollment:\n\n* Presence or past medical history of hepatic impairments, renal impairments, cardiovascular disease, gastrointestinal disease and others which are inappropriate for participating in this clinical trial\n* Past medical history of cancer, cerebral infarction or cardiac infarction\n* Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials\n* QTcF \\> 450ms at the screening examination\n* NT-proBNP \\> 125 pg/mL at the screening examination\n* Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history'}, 'identificationModule': {'nctId': 'NCT03055403', 'briefTitle': 'First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Kitasato University'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Single Continuous Intravenous Injection, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of M201-A in Healthy Japanese Subjects', 'orgStudyIdInfo': {'id': 'M201-A-CT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'M201-A Injection', 'description': 'Active Substance: M201-A Route of administration: continuous intravenous injection', 'interventionNames': ['Drug: M201-A Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline Placebo for M201-A Route of administration: continuous intravenous injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'M201-A Injection', 'type': 'DRUG', 'description': 'Active Substance: M201-A Route of administration: continuous intravenous injection', 'armGroupLabels': ['M201-A Injection']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline Placebo for M201-A Route of administration: continuous intravenous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '252-0375', 'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuji KUMAGAI', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aetas Pharma Co. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yuji KUMAGAI', 'investigatorAffiliation': 'Kitasato University'}}}}