Single Dose Study of SHR4640 in Healthy Subjects

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

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.