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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02361138

Enrollment

Registered

2015-02-11

Start date

2013-12-31

Completion date

2014-05-31

Last updated

2015-02-11

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 multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in healthy subjects.

Interventions

DRUGSHR3824

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

* 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 acceptance of blood transfusion within 8 weeks.

Design outcomes

Primary

Measure	Time frame
Plasma glucose concentration of SHR3824.	day1 and day11
Accumulation ratio of SHR3824	Up to day 13.
Urine glucose concentration of SHR3824.	day1 and day11
AUC(Area under the curve) of SHR3824.	day1 and day11 to day 13.
Cmax(the maximum concentration) of SHR3824.	day1 and day11 to day 13.
Tmax(the time reaching maximum concentration) of SHR3824.	day1 and day11 to day 13.
Halflife of SHR3824.	day1 and day11 to day 13.
CL/F of SHR3824.	day1 and day11 to day 13.
V/F of SHR3824.	day1 and day11 to day 13.

Secondary

Measure	Time frame
Serum creatinine	Days -14 to -1, 0, 2, 9, 13.
Adverse events, vital signs, physical exams , ECG, clinical labs	Days -14 to -1, 0, 13.

Countries

China

Outcome results

None listed

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