Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 2:27 PM
Study NCT ID:
NCT04229433
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2019-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multiple dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-21', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2020-01-14', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with adverse events and serious adverse events.', 'timeFrame': 'Pre-dose to 7 days after multiple dose administration.'}], 'secondaryOutcomes': [{'measure': 'PK parameter will be evaluated.', 'timeFrame': 'Pre-dose to 3 days after single dose administration', 'description': 'Area under the plasma concentration versus time curve (AUC) for single dose of SHR2285.'}, {'measure': 'Maximum observed serum concentration (Cmax) for single dose of SHR2285.', 'timeFrame': 'Pre-dose to 3 days after single dose administration'}, {'measure': 'Time to maximum observed serum concentration (Tmax) for single dose of SHR2285.', 'timeFrame': 'Pre-dose to 3 days after single dose administration'}, {'measure': 'Apparent total clearance of the drug from plasma after oral administration (CL/F) for single dose of SHR2285.', 'timeFrame': 'Pre-dose to 3 days after single dose administration.'}, {'measure': 'Apparent volume of distribution after non-intravenous administration (V/F) for single dose of SHR2285', 'timeFrame': 'Pre-dose to 3 days after single dose administration.'}, {'measure': 'Time to elimination half-life (T1/2) for single dose of SHR2285.', 'timeFrame': 'Pre-dose to 3 days after single dose administration'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) for multiple dose of SHR2285.', 'timeFrame': 'Pre-dose to 2 days after multiple dose administration'}, {'measure': 'Steady-state peak concentration (Cmax，ss) for multiple dose of SHR2285.', 'timeFrame': 'Pre-dose to 2 days after multiple dose administration'}, {'measure': 'Steady state valley concentration (Ctrough，ss) for multiple dose of SHR2285.', 'timeFrame': 'Pre-dose to 2 days after multiple dose administration'}, {'measure': 'Time to maximum observed serum concentration (Tmax) for multiple dose of SHR2285.', 'timeFrame': 'Pre-dose to 2 days after multiple dose administration.'}, {'measure': 'Time to elimination half-life (T1/2) for multiple dose of SHR2285.', 'timeFrame': 'Pre-dose to 2 days after multiple dose administration'}, {'measure': 'Steady-state apparent total clearance of the drug from plasma after oral administration (CLSS/F) for multiple dose of SHR2285.', 'timeFrame': 'Pre-dose to 2 days after multiple dose administration.'}, {'measure': 'Steady-state apparent volume of distribution after non-intravenous administration (VSS/F) for multiple dose of SHR2285.', 'timeFrame': 'Pre-dose to 2 days after multiple dose administration.'}, {'measure': 'Accumulation ratio (Racc) for multiple dose of SHR2285.', 'timeFrame': 'Pre-dose to 2 days after multiple dose administration.'}, {'measure': 'Percentage of fluctuation (PTF%) for multiple dose of SHR2285.', 'timeFrame': 'Pre-dose to 2 days after multiple dose administration.'}, {'measure': 'PD parameter will be evaluated.', 'timeFrame': 'Pre-dose to 3 days after single dose administration.', 'description': 'FXI activity; Change of APTT, PT, INR from baseline.'}, {'measure': 'PD parameter will be evaluated.', 'timeFrame': 'Pre-dose to 2 days after multiple dose administration.', 'description': 'FXI activity; Change of APTT, PT, INR from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thrombus']}, 'descriptionModule': {'briefSummary': 'The study is a randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered single dose and multiple doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. males or females, aged 18-45.\n2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP\\<140mmHg; 50mmHg ≤DBP\\<90mmHg and 50 ≤ HR \\<110 beats / min.\n3. body mass index (BMI) between 18 to 28.\n4. Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.\n\nExclusion Criteria:\n\n1. males or females, aged 18-45.\n2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP\\<140mmHg; 50mmHg ≤DBP\\<90mmHg and 50 ≤ HR \\<110 beats / min.\n3. body mass index (BMI) between 18 to 28.\n4. Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.\n\nExclusion Criteria:\n\n1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin \\> 1X ULN during screening/baseline.\n2. Serum creatinine\\> 1X ULN during screening/baseline.\n3. Abnormal coagulation function.\n4. A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.\n5. Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.\n6. Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.\n7. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive.\n\n8.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening.\n\n9.Female subjects who did not receive contraception at least 30 days before administration.'}, 'identificationModule': {'nctId': 'NCT04229433', 'briefTitle': 'The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase I, Randomized, Single -Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SHR2285-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR2285', 'description': 'Participants received one of 3 dose levels of SHR2285 administered as multiple oral doses.', 'interventionNames': ['Drug: SHR2285 tablet', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Participants received one of 3 dose levels of placebo administered as multiple oral doses.', 'interventionNames': ['Drug: SHR2285 tablet', 'Drug: Placebo']}], 'interventions': [{'name': 'SHR2285 tablet', 'type': 'DRUG', 'description': 'Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.', 'armGroupLabels': ['Placebo', 'SHR2285']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.', 'armGroupLabels': ['Placebo', 'SHR2285']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310014', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Zhejing Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}