Multiple Dose Study of SHR4640 in Healthy Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Gout; Hyperuricemia
• Intervention / Treatment: Drug: SHR4640; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • The South West Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 1mg SHR4640 or placebo	Drug: SHR4640; Day1~Day7:oral administration; Drug: placebo; Day1~Day7:oral administration
Experimental: Cohort 2; 2.5mg SHR4640 or placebo	Drug: SHR4640; Day1~Day7:oral administration; Drug: placebo; Day1~Day7:oral administration
Experimental: Cohort 3; 5mg SHR4640 or placebo	Drug: SHR4640; Day1~Day7:oral administration; Drug: placebo; Day1~Day7:oral administration
Experimental: Cohort 4; 10mg SHR4640 or placebo	Drug: SHR4640; Day1~Day7:oral administration; Drug: placebo; Day1~Day7:oral administration

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: SHR4640 pharmacokinetics pharmacodynamics
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: SHR4640-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED