The PK/PD Study of Single Dose of SHR3824 in Healthy Volunteers (SHR3824)
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring SHR3824 Type 2 diabetes mellitus SGLT2
Eligibility Criteria
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.
Sites / Locations
- Shanghai Xuhui Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Cohort 6
Cohort 7
SHR3824 2.5 mg/day or placebo.
SHR3824 5 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
SHR3824 10 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
SHR3824 25 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
SHR3824 50 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
SHR3824 100 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
SHR3824 200 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.