Single Dose Study of SHR4640 in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of Single Doses of SHR4640 in Healthy Subjects

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.

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.