Multiple 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

NCT02890966

SHR4640-102

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age between 18 and 55, male;
2. Body weight≥50, BMI:19-25kg/m2;

3.4 mg/dL≤Screening serum urate level≤7 mg/dL;

4.Medically stable based on physical examination, laboratory results, vital sign measurements, 12-lead electrocardiogram, abdomen B-ultrasound and Chest X-ray examination at screening.

Exclusion criteria

1. Serum creatinine>upper limits of normal(ULN);
2. Alanine aminotransferase and/or Aspartate aminotransferase>2×ULN, total bilirubin>1.5×ULN, glutamyltransferase>3×ULN;
3. History of hyperuricemia or gout;
4. History or suspicion of kidney stones;
5. Positive results for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 4 patient groups

Cohort 1

Experimental group

Description:

1mg SHR4640 or placebo

Treatment:

Drug: placebo

Drug: SHR4640

Cohort 2

Experimental group

Description:

2.5mg SHR4640 or placebo

Treatment:

Drug: placebo

Drug: SHR4640

Cohort 3

Experimental group

Description:

5mg SHR4640 or placebo

Treatment:

Drug: placebo

Drug: SHR4640

Cohort 4

Experimental group

Description:

10mg SHR4640 or placebo

Treatment:

Drug: placebo

Drug: SHR4640