Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-30 @ 6:26 PM
Study NCT ID:
NCT05369767
Status:
UNKNOWN
Last Update Posted:
2022-11-30
First Post:
2022-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064346', 'term': 'Sagittal Abdominal Diameter'}], 'ancestors': [{'id': 'D049628', 'term': 'Body Size'}, {'id': 'D001837', 'term': 'Body Weights and Measures'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000886', 'term': 'Anthropometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'SHR-2004 injection compared with placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-29', 'studyFirstSubmitDate': '2022-05-06', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'up to day 113'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prevention of Arterial and Venous Thrombosis']}, 'referencesModule': {'references': [{'pmid': '39166425', 'type': 'DERIVED', 'citation': 'Ma T, Weng Z, Cao B, Dong Y, Deng C, Huang L, Yang Y, Wang Y, Shen C, Wang L, Shen K, Li J. The first-in-human study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the factor XI monoclonal antibody SHR-2004 in healthy subjects. Expert Opin Investig Drugs. 2024 Oct;33(10):1075-1082. doi: 10.1080/13543784.2024.2391837. Epub 2024 Aug 22.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the safety and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-2004 injection in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. males or females, aged 18-55;\n2. body mass index (BMI) between 19 kg/m2 to 28 kg/m2, and a total body weight: male ≥50.0 kg and \\<90.0 kg; female ≥45.0 kg and \\<90.0 kg.\n\nExclusion Criteria:\n\n1. previous medical history of coagulation or bleeding disorders;\n2. known risks of bleeding or thrombosis, such as recurrent gingival bleeding, spontaneous bleeding, haemorrhoids, gastrointestinal ulcers, or other high-risk bleeding diseases.'}, 'identificationModule': {'nctId': 'NCT05369767', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Suncadia Pharmaceuticals Co., Ltd'}, 'officialTitle': 'A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SHR-2004-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAD, SHR-2004', 'description': 'Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 injection', 'interventionNames': ['Drug: SAD, SHR-2004']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SAD, SHR-2004 placebo', 'description': 'Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 placebo injection', 'interventionNames': ['Drug: SAD, SHR-2004 placebo']}], 'interventions': [{'name': 'SAD, SHR-2004', 'type': 'DRUG', 'description': 'Ascending dose', 'armGroupLabels': ['SAD, SHR-2004']}, {'name': 'SAD, SHR-2004 placebo', 'type': 'DRUG', 'description': 'Ascending dose', 'armGroupLabels': ['SAD, SHR-2004 placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Affiliated Drum Tower Hospital of Nanjing University Medical school', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Suncadia Pharmaceuticals Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}