Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of DA-302168S Tablets

Inclusion Criteria:

• Age 18 to 55 years old (including 18 and 55 years old), male or female.

• Weight: male ≥50kg, female ≥45kg, body mass index (BMI) in the range of 19.0 ~ 28.0kg/m2 (including the end value).

• Subjects and their spouses or partners did not plan to become pregnant or plan todonate sperm or ovum during the study period until 3 months after the last dose, andagreed to use at least one acceptable and effective contraceptive method.

• No clinically significant abnormalities identified in the judgement of investigatorat screening.

• Written informed consent prior to any study specific procedures.

Exclusion Criteria:

• subjects with a history of abnormal clinical presentation, diseases to be excluded,including but not limited to diseases of the nervous system, cardiovascular system,blood and lymphatic system, immune system, endocrine system, renal, hepatic,gastrointestinal, respiratory, metabolic, and skeletal systems, and a history ofmalignant tumors, which are judged to be clinically significant by the Investigator.

• Use of any medication (including prescription, over-the-counter, herbal, etc.) ornutraceutical within 14 days prior to the first dose.

• May have any contraindications, allergies or hypersensitivity to DA-302168S Tablets (both test drug and placebo) or its excipients, GLP-1RA, DPP-4 analogues.

• Previous family history of medullary thyroid carcinoma or type 2 multiple endocrineadenoma syndrome.

• History or evidence of any of the following conditions:

1. Decompensated heart failure (New York Heart Association (NYHA) CardiacClassification III and IV [Appendix 5: NYHA Heart Failure Classification]),cardiac arrhythmias (e.g., supraventricular tachycardia, atrial fibrillation,atrial flutter, second or third degree atrioventricular block, QTcF intervals > 450 milliseconds for men or > 470 milliseconds for women [Appendix 8:Fridericia Method Corrected QT Interval Formula], PR intervals > 220milliseconds, etc.) prior to the first administration of the study drug. (e.g.,supraventricular tachycardia, atrial fibrillation, atrial flutter, grade II orIII AV block, QTcF interval >450 ms in males or >470 ms in females [Appendix 8:Formula for Correcting QT Intervals by the Fridericia Method], PR interval >220ms, etc.) and who, in the opinion of the investigator, are unsuitable forparticipation in this study;

2. Serious trauma or acute infection that may affect glycemic control within 4weeks prior to screening;

3. Positive results for any of the Hepatitis B Surface Antigen, Hepatitis CAntibody, Syphilis Spirochete Antibody, or Human Immunodeficiency Virus (HIV)Antibody;

4. Mental or neurological illness prior to screening, unwillingness tocommunicate, or a language barrier that prevents full understanding andcooperation;

5. Other medical or psychiatric conditions that may increase the risk ofparticipation in the study or that, in the judgment of the Investigator, maymake the subject unsuitable for participation in the study, including a recenthistory (within the past two years) of major depression or other serious mentaldisorder, or any history of attempted suicide.

• Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg prior to thefirst dose and who, in the opinion of the investigator, are not suitable forparticipation in the study.

• Those who screen positive for substance abuse or have a history of substance abusewithin the past five years or have used drugs in the 3 months prior to screening.

• Those who have participated in a clinical trial of another drug within 3 monthsprior to screening and have received any of the clinical trial drugs.

• Elective surgery was planned during the study period.

• Those who have donated or lost ≥200mL of blood, received a blood transfusion, orused blood products within 3 months prior to screening.

• Female subjects are pregnant or lactating.

• Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day, or who consumed tea, coffee and/orcaffeinated beverages within 48 hours prior to the first dose of the drug, or whowere unable to discontinue consumption during the trial period

• Previous chronic intake of xanthine- or grapefruit-rich beverages or foods, orconsumption of any xanthine- or grapefruit-rich product within 48 hours prior to thefirst dose.

• Smokers or those who smoked an average of ≥5 cigarettes per day in the 3 monthsprior to screening, or those who were unable to stop using any tobacco-basedproducts during the trial.

• Heavy drinkers or regular drinkers in the 3 months prior to screening, i.e., thosewho consume more than 14 standardized units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol by volume spirits or 150 mL of wine) or thosewho have a positive breath test for alcohol at baseline or who are unable todiscontinue the use of any alcohol-containing product during the test period.