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

Phase 2

• Conditions: Hyperuricemia
• Interventions: Drug: SHR4640 dose1 plus Febuxostat dose1; Drug: SHR4640 dose1 plus Febuxostat dose2; Drug: SHR4640 dose2 plus Febuxostat dose3

• Registration Number: NCT04180982
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-11-26
• Last Update Submitted: 2019-11-28
• Study First Posted: 2019-11-29
• Last Update Posted: 2019-12-02
• Study Start: 2019-12-03
• Primary Completion: 2020-07-30
• Study Completion: 2020-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	SHR4640 dose1 plus Febuxostat dose1	SHR4640 dose1 Oral Tablet plus Febuxostat dose1 Oral Tablet Day1\~Day28 qd.
Treatment group B	SHR4640 dose1 plus Febuxostat dose2	SHR4640 dose1 Oral Tablet plus Febuxostat dose2 Oral Tablet Day1\~Day28 qd.
Treatment group C	SHR4640 dose2 plus Febuxostat dose3	SHR4640 dose2 Oral Tablet plus Febuxostat dose3 Oral Tablet Day1\~Day28 qd.

Primary Outcome Measures

Name	Time	Method
Adverse Events(AEs) and Serious Adverse Events(SAEs)	Up to week 4	Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events, incidence of drug related adverse events (safety and tolerability)

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with a serum uric level≤360μmol/L	At week1, 2, 3 and 4
Percentage change from baseline in serum uric level .	At week1, 2, 3 and 4
Actual change from baseline in serum uric level	At week1, 2, 3 and 4