The PK/PD Study of Single Dose of SHR3824 in Healthy Volunteers

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following Single Dose of SHR3824 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02356224

Acronym

SHR3824

Enrollment

Registered

2015-02-05

Start date

2013-06-30

Completion date

2013-12-31

Last updated

2015-02-05

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

Conditions

Type 2 Diabetes

Keywords

SHR3824 Type 2 diabetes mellitus SGLT2

Brief summary

SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose study the investigators evaluated the safety, tolerablity and PK/PD profiles of SHR3824 in healthy subjects.

Interventions

DRUGSHR3824

A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.

DRUGPlacebo

A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.

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

* Chinese male and female subjects aged 18 to 45 years. * BMI:18 -25 kg/m2 . * Healthy according to medical history, physical examination findings, 12-lead ECG findings, and clinical laboratory evaluations.

Exclusion criteria

* History of or current clinically significant medical illness as determined by the Investigator. * History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose. * Pregnancy or breastfeeding . * Significant acute or chronic medical illness, including renal impairment, or recent surgery. * Donation of blood or plasma within the 4 weeks prior to the start of the study or acception of blood transfusion within 8 weeks.

Design outcomes

Primary

Measure	Time frame
Total 24-hour urinary glucose excretion as a measure of pharmacodynamic effect.	24h after dosing
SHR3824 and its metabolites of concentrations to characterize SHR3824 harmacokinetics.	Up to 72h after dosing

Secondary

Measure	Time frame
The number of patients with adverse events as a measure of safety and tolerability	up to day 72h after dosing

Countries

China

Outcome results

None listed

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