Back to results

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

Primary Purpose

Hyperuricemia

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SHR4640 dose1 plus Febuxostat dose1

SHR4640 dose1 plus Febuxostat dose2

SHR4640 dose2 plus Febuxostat dose3

About this trial

This is an interventional treatment trial for Hyperuricemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Treatment group A

Treatment group B

Treatment group C

Arm Description

SHR4640 dose1 Oral Tablet plus Febuxostat dose1 Oral Tablet Day1~Day28 qd.

SHR4640 dose1 Oral Tablet plus Febuxostat dose2 Oral Tablet Day1~Day28 qd.

SHR4640 dose2 Oral Tablet plus Febuxostat dose3 Oral Tablet Day1~Day28 qd.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Percentage of subjects with a serum uric level≤360μmol/L

Percentage change from baseline in serum uric level .

Actual change from baseline in serum uric level

Full Information

NCT ID

NCT04180982

First Posted

November 26, 2019

Last Updated

November 28, 2019

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04180982

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 3, 2019 (Anticipated)

Primary Completion Date

July 30, 2020 (Anticipated)

Study Completion Date

August 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperuricemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group A

Arm Type

Experimental

Arm Description

SHR4640 dose1 Oral Tablet plus Febuxostat dose1 Oral Tablet Day1~Day28 qd.

Arm Title

Treatment group B

Arm Type

Experimental

Arm Description

SHR4640 dose1 Oral Tablet plus Febuxostat dose2 Oral Tablet Day1~Day28 qd.

Arm Title

Treatment group C

Arm Type

Experimental

Arm Description

SHR4640 dose2 Oral Tablet plus Febuxostat dose3 Oral Tablet Day1~Day28 qd.

Intervention Type

Drug

Intervention Name(s)

SHR4640 dose1 plus Febuxostat dose1

Intervention Description

Tablet,dose1,QD

Intervention Type

Drug

Intervention Name(s)

SHR4640 dose1 plus Febuxostat dose2

Intervention Description

Tablet,dose1, dose2 QD

Intervention Type

Drug

Intervention Name(s)

SHR4640 dose2 plus Febuxostat dose3

Intervention Description

Tablet,dose2, dose3 QD

Primary Outcome Measure Information:

Title

Adverse Events(AEs) and Serious Adverse Events(SAEs)

Description

Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events, incidence of drug related adverse events (safety and tolerability)

Time Frame

Up to week 4

Secondary Outcome Measure Information:

Title

Percentage of subjects with a serum uric level≤360μmol/L

Time Frame

At week1, 2, 3 and 4

Title

Percentage change from baseline in serum uric level .

Time Frame

At week1, 2, 3 and 4

Title

Actual change from baseline in serum uric level

Time Frame

At week1, 2, 3 and 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liu Yi

Phone

028-85423237

hxyyhfb@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liu Yi

Organizational Affiliation

West China Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs