Multiple Dose Study of SHR4640 in Healthy Subjects

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

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of SHR4640 in Healthy Subjects

Conditions
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Gout; Hyperuricemia

Intervention / Treatment
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* Drug: SHR4640
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 55, male; 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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>1mg SHR4640 or placebo | Drug: SHR4640<br>* Day1 Day7:oral administration<br>Drug: placebo<br>* Day1 Day7:oral administration<br>|
| Experimental: Cohort 2<br>2.5mg SHR4640 or placebo | Drug: SHR4640<br>* Day1 Day7:oral administration<br>Drug: placebo<br>* Day1 Day7:oral administration<br>|
| Experimental: Cohort 3<br>5mg SHR4640 or placebo | Drug: SHR4640<br>* Day1 Day7:oral administration<br>Drug: placebo<br>* Day1 Day7:oral administration<br>|
| Experimental: Cohort 4<br>10mg SHR4640 or placebo | Drug: SHR4640<br>* Day1 Day7:oral administration<br>Drug: placebo<br>* Day1 Day7:oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Clinical significant changes from baseline up to Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration(Cmax)(of single dose and at stable status) |  | Up to Day 10 | 
| Area under the plasma concentration versus time curve(AUC)(of single dose and at stable status) |  | Up to Day 10 | 
| Half-time(T1/2)(of single dose and at stable status) |  | Up to Day 10 | 
| Time to the peak plasma concentration(Tmax)(of single dose and at stable status) |  | Up to Day 10 | 
| Changes in serum uric acid concentration from baseline |  | Up to Day 10 | 
| Changes in urinary uric acid excretion from baseline |  | Up to Day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SHR4640 pharmacokinetics pharmacodynamics