Single Dose Study of SHR4640 in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02815839

Enrollment

Registered

2016-06-28

Start date

2015-11-30

Completion date

2017-02-28

Last updated

2017-02-28

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

Conditions

Gout; Hyperuricemia

Keywords

urate transporter 1, SHR4640, single ascending dose, pharmacokinetics, pharmacodynamics

Brief summary

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

Interventions

DRUGSHR4640

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Body weight≥50, BMI:19-24kg/m2; * Screening serum urate level ≤ 4.5 mg/dL for male and ≤ 3.5 mg/dL for female; * Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;

Exclusion criteria

* History of hyperuricemia or gout. * Pregnancy or breastfeeding; * History or suspicion of kidney stones; * serum creatinine\>1.5mg/dl for male, \>1.2mg/dl for female; * alanine aminotransferase and/or aspartate aminotransferase\>2 upper limit of normal, or total bilirubin\>2.5 upper limit of normal.

Design outcomes

Primary

Measure	Time frame
Adverse events	Clinical significant changes from baseline up to to Day 15; from baseline up to Day 19 for 7.5mg dose group

Secondary

Measure	Time frame	Description
Area under the plasma concentration versus time curve (AUC)	up to day 4; up to day 11 for 7.5mg dose group	—
Half-time (T1/2)	up to day 4; up to day 11 for 7.5mg dose group	—
Time to the peak plasma concentration (Tmax)	up to day 4; up to day 11 for 7.5mg dose group	—
Cmax of SHR4640 dosed after high-fat meal in 7.5mg dose group	up to day 11	—
Peak Plasma Concentration (Cmax)	up to day 4; up to day 11 for 7.5mg dose group	—
T1/2 of SHR4640 dosed after high-fat meal in 7.5mg dose group	up to day 11	—
Tmax of SHR4640 dosed after high-fat meal in 7.5mg dose group	up to day 11	—
Changes in serum uric acid concentration from baseline	up to day 4; up to day 11 for 7.5mg dose group	absolute and percent changes in serum acid concentration
Changes in urinary uric acid excretion from baseline	up to day 4; up to day 11 for 7.5mg dose group	percent changes in urinary uric acid excretion from baseline
AUC of SHR4640 dosed after high-fat meal in 7.5mg dose group	up to day 11	—

Countries

China

Outcome results

None listed

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