Multiple Dose Study of SHR4640 in Healthy Subjects

Phase 1

Completed

• Conditions: Gout; Hyperuricemia
• Interventions: Drug: SHR4640; Drug: placebo

• Registration Number: NCT02890966
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-07
• Primary Completion: 2017-02
• Status Verified: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	placebo	1mg SHR4640 or placebo
Cohort 2	placebo	2.5mg SHR4640 or placebo
Cohort 3	SHR4640	5mg SHR4640 or placebo
Cohort 1	SHR4640	1mg SHR4640 or placebo
Cohort 4	SHR4640	10mg SHR4640 or placebo
Cohort 2	SHR4640	2.5mg SHR4640 or placebo
Cohort 3	placebo	5mg SHR4640 or placebo
Cohort 4	placebo	10mg SHR4640 or placebo

Primary Outcome Measures

Name	Time	Method
Adverse events	Clinical significant changes from baseline up to Day 10

Secondary Outcome Measures

Name	Time	Method
Half-time(T1/2)(of single dose and at stable status)	Up to Day 10
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
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

Trial Locations

Locations (1)

The South West Hospital; 🇨🇳 Chongqing, Chongqing, China