Single Dose Study of SHR4640 in Healthy Subjects

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Gout; Hyperuricemia

Treatments: Drug: Placebo; Drug: SHR4640

Study type: Interventional

Funder types: Industry

Identifiers

NCT02815839

SHR4640-101

Details and patient eligibility

About

The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.

Enrollment: 50 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight≥50, BMI:19-24kg/m2;
• Screening serum urate level ≤ 4.5 mg/dL for male and ≤ 3.5 mg/dL for female;
• Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;

Exclusion criteria

• History of hyperuricemia or gout.
• Pregnancy or breastfeeding;
• History or suspicion of kidney stones;
• serum creatinine>1.5mg/dl for male, >1.2mg/dl for female;
• alanine aminotransferase and/or aspartate aminotransferase>2 upper limit of normal, or total bilirubin>2.5 upper limit of normal.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 5 patient groups

Cohort 1

Experimental group

Description:

2.5-mg SHR4640 or placebo

Treatment:

Drug: Placebo

Drug: SHR4640

Cohort 2

Experimental group

Description:

5-mg SHR4640 or placebo

Treatment:

Drug: Placebo

Drug: SHR4640

Cohort 3

Experimental group

Description:

7.5-mg SHR4640 or placebo

Treatment:

Drug: Placebo

Drug: SHR4640

Cohort 4

Experimental group

Description:

10-mg SHR4640 or placebo

Treatment:

Drug: Placebo

Drug: SHR4640

Cohort 5

Experimental group

Description:

20-mg SHR4640 or placebo

Treatment:

Drug: Placebo

Drug: SHR4640