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

A Phase II, MultiCenter, Double-Blind Study to Evaluate the Efficacy and Safety of SHR4640 and Febuxostat in Subjects With Hyperuricemia

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

Study Overview

• Status: Unknown
• Conditions: Hyperuricemia
• Intervention / Treatment: Drug: SHR4640 dose1 plus Febuxostat dose1; Drug: SHR4640 dose1 plus Febuxostat dose2; Drug: SHR4640 dose2 plus Febuxostat dose3

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; SHR4640 dose1 Oral Tablet plus Febuxostat dose1 Oral Tablet Day1~Day28 qd.	Drug: SHR4640 dose1 plus Febuxostat dose1; Tablet,dose1,QD
Experimental: Treatment group B; SHR4640 dose1 Oral Tablet plus Febuxostat dose2 Oral Tablet Day1~Day28 qd.	Drug: SHR4640 dose1 plus Febuxostat dose2; Tablet,dose1, dose2 QD
Experimental: Treatment group C; SHR4640 dose2 Oral Tablet plus Febuxostat dose3 Oral Tablet Day1~Day28 qd.	Drug: SHR4640 dose2 plus Febuxostat dose3; Tablet,dose2, dose3 QD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Liu Yi, West China Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 3, 2019
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): August 30, 2020

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 28, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia; Antirheumatic Agents; Gout Suppressants; Febuxostat
• Other Study ID Numbers: SHR4640-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No