Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-24 @ 9:38 PM
Study NCT ID:
NCT02890966
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2016-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Dose Study of SHR4640 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}, {'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720748', 'term': 'ruzinurad'}]}}, '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': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2016-09-01', 'studyFirstSubmitQcDate': '2016-09-01', 'lastUpdatePostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Clinical significant changes from baseline up to Day 10'}], 'secondaryOutcomes': [{'measure': 'Peak Plasma Concentration(Cmax)(of single dose and at stable status)', 'timeFrame': 'Up to Day 10'}, {'measure': 'Area under the plasma concentration versus time curve(AUC)(of single dose and at stable status)', 'timeFrame': 'Up to Day 10'}, {'measure': 'Half-time(T1/2)(of single dose and at stable status)', 'timeFrame': 'Up to Day 10'}, {'measure': 'Time to the peak plasma concentration(Tmax)(of single dose and at stable status)', 'timeFrame': 'Up to Day 10'}, {'measure': 'Changes in serum uric acid concentration from baseline', 'timeFrame': 'Up to Day 10'}, {'measure': 'Changes in urinary uric acid excretion from baseline', 'timeFrame': 'Up to Day 10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SHR4640 pharmacokinetics pharmacodynamics'], 'conditions': ['Gout; Hyperuricemia']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to assess the tolerance, pharmacokinetic and pharmacodynamic properties of multiple dose adminstration of SHR4640 in healthy volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 55, male;\n2. Body weight≥50, BMI:19-25kg/m2;\n\n3.4 mg/dL≤Screening serum urate level≤7 mg/dL;\n\n4.Medically stable based on physical examination, laboratory results, vital sign measurements, 12-lead electrocardiogram, abdomen B-ultrasound and Chest X-ray examination at screening.\n\nExclusion Criteria:\n\n1. Serum creatinine\\>upper limits of normal(ULN);\n2. Alanine aminotransferase and/or Aspartate aminotransferase\\>2×ULN, total bilirubin\\>1.5×ULN, glutamyltransferase\\>3×ULN;\n3. History of hyperuricemia or gout;\n4. History or suspicion of kidney stones;\n5. Positive results for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test.'}, 'identificationModule': {'nctId': 'NCT02890966', 'briefTitle': 'Multiple Dose Study of SHR4640 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of SHR4640 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SHR4640-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': '1mg SHR4640 or placebo', 'interventionNames': ['Drug: SHR4640', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': '2.5mg SHR4640 or placebo', 'interventionNames': ['Drug: SHR4640', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': '5mg SHR4640 or placebo', 'interventionNames': ['Drug: SHR4640', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': '10mg SHR4640 or placebo', 'interventionNames': ['Drug: SHR4640', 'Drug: placebo']}], 'interventions': [{'name': 'SHR4640', 'type': 'DRUG', 'description': 'Day1\\~Day7:oral administration', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Day1\\~Day7:oral administration', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The South West Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}