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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02890966

Enrollment

Registered

2016-09-07

Start date

2016-07-31

Completion date

2017-03-31

Last updated

2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout; Hyperuricemia

Keywords

SHR4640 pharmacokinetics pharmacodynamics

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.

Interventions

DRUGSHR4640

Day1\ Day7:oral administration

DRUGplacebo

Day1\ Day7:oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Peak Plasma Concentration(Cmax)(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
Time to the peak plasma concentration(Tmax)(of single dose and at stable status)	Up to Day 10

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026