Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-05 @ 8:51 AM
Study NCT ID:
NCT07024160
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of MT1011 Injection in Healthy 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': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-06-09', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)and treatment-related adverse events (TEAEs).', 'timeFrame': 'up to Day 14', 'description': 'The occurrence of all adverse events (AEs), serious adverse events (SAEs)'}], 'secondaryOutcomes': [{'measure': 'Cmax of MT1011', 'timeFrame': 'Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.', 'description': 'Cmax - Maximum plasma concentration'}, {'measure': 'Tmax of MT1011', 'timeFrame': 'Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.', 'description': 'Tmax - Time to reach Cmax'}, {'measure': 'T1/2 of MT1011', 'timeFrame': 'Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.', 'description': 't1/2 - Elimination half-life'}, {'measure': 'AUC0-tau of MT1011', 'timeFrame': 'Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.', 'description': 'AUC0-tau - Area under the plasma concentration-time curve during one dosing interval'}, {'measure': 'AUC0-t of MT1011', 'timeFrame': 'Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.', 'description': 'AUC0-t - Area under the plasma concentration-time curve from time zero to the last measurable concentration'}, {'measure': 'Whole blood clotting time', 'timeFrame': 'Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.', 'description': 'Whole blood clotting time'}, {'measure': 'Activated partial thromboplastin time', 'timeFrame': 'Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.', 'description': 'Activated partial thromboplastin time'}, {'measure': 'Prothrombin time', 'timeFrame': 'Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.', 'description': 'Prothrombin time'}, {'measure': 'fibrinogen', 'timeFrame': 'Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.', 'description': 'fibrinogen'}, {'measure': 'International normalized ratios', 'timeFrame': 'Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.', 'description': 'International normalized ratios'}, {'measure': 'Thrombin time', 'timeFrame': 'Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.', 'description': 'Thrombin time'}, {'measure': 'Factor Xa activity', 'timeFrame': 'Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.', 'description': 'Factor Xa activity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of Anticoagulation']}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized,double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) of MT1011 injection in healthy adult subjects. Includes 5 dose cohorts, with 40 subjects planned for enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male or female subjects (with at least 1/4 being either female or male), aged 18 to 45 years (inclusive) at screening;\n2. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening, with a Body Mass Index \\[BMI = weight (kg) / height² (m²)\\] within the range of 18.5 to 26.0 kg/m² (inclusive);\n3. Subjects must provide informed consent for this study prior to participation and voluntarily sign a written informed consent form;\n4. Subjects must be able to maintain good communication with the investigators.\n\nExclusion Criteria:\n\n1. Subjects with abnormal and clinically significant findings in vital signs, physical examination, laboratory tests (blood routine, urinalysis, blood biochemistry, coagulation function), abdominal ultrasound, or chest X-ray as determined by the investigator;\n2. Women who are pregnant or breastfeeding, or female subjects with positive pregnancy tests; Subjects (or their partners) planning pregnancy, or planning to donate sperm/ova during the study or within'}, 'identificationModule': {'nctId': 'NCT07024160', 'briefTitle': 'Phase I Study of MT1011 Injection in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shaanxi Micot Pharmaceutical Technology Co., Ltd.'}, 'officialTitle': 'A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose (SAD) Administration of MT1011 Injection in Healthy Subjects', 'orgStudyIdInfo': {'id': 'MT1011-I-C02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MT1011', 'description': 'Interventional: The SAD study involves single administration of MT1011', 'interventionNames': ['Drug: MT1011']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo: The SAD study involves single administration of Placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MT1011', 'type': 'DRUG', 'description': 'MT1011 is a novel synthetic small molecule anticoagulant reversal agent for reversing anticoagulant effects including factor IIa and Xa inhibitors.', 'armGroupLabels': ['MT1011']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'This intervention contains no active ingredients', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100038', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao Hua Hao, Ph.D. in Medicine', 'role': 'CONTACT', 'email': 'xiaohualuck@sina.com', 'phone': '010-63926883'}], 'facility': 'Beijing Shijitan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiao Hua Hao, Ph.D. in Medicine', 'role': 'CONTACT', 'email': 'xiaohualuck@sina.com', 'phone': '010-63926883'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaanxi Micot Pharmaceutical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}