Type 2 Diabetes Mellitus
Conditions
Interventions
SAD group:HS-10501 tablet, from low to high, 10 mg, 30 mg, 75 mg, 150 mg, 250 mg and 360 mg dose or placebo
MAD group:The MAD phase contained 3 dose groups, the 1st dose group (120 mg BID dose group) and the 3rd dose group (180 mg BID dose group) were administered twice daily for 28 consecutive days. The 2n
Sponsors
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
15 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Subjects have a full understanding of the content, process and possible adverse reactions of the test, and voluntarily sign the informed consent form; 2. Healthy men and women between the ages of 18 and 55 (including the threshold); 3. Men weighing not less than 50.0 kg and women weighing not less than 45.0 kg, with BMI within the range of 19.0 to 28.0 (including the threshold value) according to the body mass index (BMI) = weight/height2 (kg/m2); 4. Agree to abstain from smoking, alcohol, food and beverages containing xanthine or caffeine (including chocolate, tea, coffee, cola, etc.) and to avoid strenuous exercise from 48 hours prior to the administration of the drug to the end of the last visit; 5. agrees to abstain from ingesting grapefruit, grapefruit juice, bitter orange, bitter orange juice or other products containing grapefruit or bitter orange, mulberry juice, mustard greens (such as collard greens, bean greens, kale, Brussels sprouts, and mustard greens), or charcoal-roasted meats from 7 days prior to administration until the end of the final visit; 6. agree to use effective contraception from the date of signing the informed consent form until 30 days after the last dose; 7. male or female subjects agree to refrain from donating sperm or eggs from the date of signed informed consent until 30 days after the last dose; 8. Female subjects of childbearing potential must have a negative blood pregnancy test report within 3 days prior to dosing.
Exclusion criteria
Exclusion criteria: 1. women who are pregnant or breastfeeding; 2. those with a history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, psychiatric, neurologic, hematologic, immunologic, or metabolic abnormalities (e.g., unexplained recurrent hypoglycemia) that are assessed by the investigator to be inappropriate for participation in this trial; 3. Abnormal and clinically significant vital signs, physical examination, laboratory tests, or 12-lead electrocardiogram results during the screening period (e.g., QT intervals corrected for heart rate (Fridericia's formula) QTcF >450 msec for men and >470 msec for women; PR intervals >200 msec, etc.); 4. Major surgery within 3 months prior to screening or planned surgery during the study period; 5. those who have had or currently have a serious infection such as cellulitis, pneumonia or sepsis within 30 days prior to screening 6. Albuminous aminotransferase (ALT), albuminous aminotransferase (AST), and alkaline phosphatase (ALP) greater than the upper limit of normal; 7. Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis serum-specific antibody (TP-Ab) positive; 8. Glycosylated hemoglobin >6.0% and fasting blood glucose =3.9 mmol/L (70 mg/dL) or =6.1 mmol/L (110 mg/dL) during the screening period; 9. History of substance abuse and drug use within 1 year prior to screening, or positive urine drug screen; 10. smokers who are addicted to tobacco or have smoked an average of 5 or more cigarettes per day in the 3 months prior to screening 11. history of alcohol abuse or consumption of more than 14 units of alcohol (1 unit = 285 mL of beer, 25 mL of spirits (=35% alcohol by volume), 150 mL of wine) in a single occasion within the last 2 weeks, or a positive blood test for alcohol at screening; 12. Participated in a clinical trial of any drug or medical device within 3 months prior to screening (except those who did not receive the drug or test device for the trial); 13. have donated or lost = 400 mL of blood or received a blood transfusion within 3 months prior to screening; or have donated or lost = 200 mL of blood within 1 month prior to screening 14. have received systemic steroid therapy, immunomodulator therapy, or chemotherapy within 3 months prior to screening, or are likely to receive these treatments during the study period 15. have severe allergic disease or suspected allergy to any component of the study medication, allergic sensitivities (multiple drug and food allergies); 16. subjects with a comorbid condition that could significantly interfere with the absorption of drugs or nutrients, as determined by the investigator, such as the presence of clinically significant gastrointestinal disease (e.g., active inflammatory bowel disease) and the presence of symptoms of gastrointestinal disturbances; or the presence of any condition that could interfere with the absorption of drugs, such as major or total gastrectomy, sleeve gastrectomy, gastric bypass resection, or resection of any region of the intestinal tract; 17. persons with a history of pancreatitis (chronic pancreatitis or idiopathic acute pancreatitis), serum amylase or lipase greater than the upper limit of normal; 18. previous history or family history of medullary thyroid carcinoma, multiple endocrine adenomatosis type 2 or screening calcitonin = 50 ng/L; 19. dieting or undergoing weight loss treatment within 3 months prior to dosing (for whatever reason) or change in weight of more
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safty outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome;PD outcome; | — |
Countries
China
Contacts
Public ContactWei Hu
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed