A Safety and Efficacy Study of SHR4640 and Febuxostat in Subjects With Hyperuricemia
NCT ID: NCT04180982
Last Updated: 2019-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
84 participants
INTERVENTIONAL
2019-12-03
2020-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment group A
SHR4640 dose1 Oral Tablet plus Febuxostat dose1 Oral Tablet Day1\~Day28 qd.
SHR4640 dose1 plus Febuxostat dose1
Tablet,dose1,QD
Treatment group B
SHR4640 dose1 Oral Tablet plus Febuxostat dose2 Oral Tablet Day1\~Day28 qd.
SHR4640 dose1 plus Febuxostat dose2
Tablet,dose1, dose2 QD
Treatment group C
SHR4640 dose2 Oral Tablet plus Febuxostat dose3 Oral Tablet Day1\~Day28 qd.
SHR4640 dose2 plus Febuxostat dose3
Tablet,dose2, dose3 QD
Interventions
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SHR4640 dose1 plus Febuxostat dose1
Tablet,dose1,QD
SHR4640 dose1 plus Febuxostat dose2
Tablet,dose1, dose2 QD
SHR4640 dose2 plus Febuxostat dose3
Tablet,dose2, dose3 QD
Eligibility Criteria
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Inclusion Criteria
* Screening sUA value ≥8mg/dl;
* Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
Exclusion Criteria
* ALT、AST、TBIL\>1.5ULN;
* History of kidney stones or screening kidney stones by B-ultrasound；
* History of malignancy；
* History of xanthinuria；
* Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood.
18 Years
65 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Liu Yi
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Central Contacts
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Other Identifiers
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SHR4640-202
Identifier Type: -
Identifier Source: org_study_id
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