A Safety and Efficacy Study of SHR4640 and Febuxostat in Subjects With Hyperuricemia

• Status: Unknown status
• Trial end date: 2020-08-30
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to assess the Safety and Efficacy of SHR4640 and Febuxostat in patients with Hyperuricemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Febuxostat

Criteria

Inclusion Criteria:

• Subject has a body mass index ≥18 and ≤30 kg/m2;

• 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:

• Subject known or suspected of being sensitive to the study drugs or its ingredient；

• 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.