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

Hengrui Medicine

Status and phase: Unknown; Phase 2

Conditions: Hyperuricemia

Treatments: Drug: SHR4640 dose1 plus Febuxostat dose1; Drug: SHR4640 dose2 plus Febuxostat dose3; Drug: SHR4640 dose1 plus Febuxostat dose2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04180982

SHR4640-202

Details and patient eligibility

About

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

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 3 patient groups

Treatment group A

Experimental group

Description:

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

Treatment:

Drug: SHR4640 dose1 plus Febuxostat dose1

Treatment group B

Experimental group

Description:

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

Treatment:

Drug: SHR4640 dose1 plus Febuxostat dose2

Treatment group C

Experimental group

Description:

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

Treatment:

Drug: SHR4640 dose2 plus Febuxostat dose3