The objective of the study is to assess the tolerance, pharmacokinetic and pharmacodynamic
properties of multiple dose adminstration of SHR4640 in healthy volunteers.
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Full eligibility criteria for NCT02890966
Ages eligible for Study
18 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
Age between 18 and 55, male;
Body weight≥50, BMI:19-25kg/m2;
4 mg/dL≤Screening serum urate level≤7 mg/dL;
Medically stable based on physical examination, laboratory results, vital sign measurements, 12-lead electrocardiogram, abdomen B-ultrasound and Chest X-ray examination at screening.
Serum creatinine＞upper limits of normal(ULN);
Alanine aminotransferase and/or Aspartate aminotransferase＞2×ULN, total bilirubin＞1.5×ULN, glutamyltransferase＞3×ULN;
History of hyperuricemia or gout;
History or suspicion of kidney stones;
Positive results for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test.
All locations for NCT02890966
The South West Hospital
Chongqing, Chongqing, China, 400042
View full eligibility
Tris trial is registered with FDA with number: NCT02890966. The sponsor of the trial is Jiangsu HengRui Medicine Co., Ltd. and it is looking for 48 volunteers for the current phase.
Official trial title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of SHR4640 in Healthy Subjects
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