Phase Ia Clinical Study of HDM1005 Injection

Exclusion Criteria

• •1. Previous diagnosis of type 1, type 2, or other types of diabetes
• •2. History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenomatosis type 2
• •3. As determined by the investigator, the subject has a co-existing disease or condition that affects gastric emptying or gastrointestinal nutrient absorption. Or a history of acute pancreatitis or acute gallbladder disease within 3 months prior to signing the ICF
• •4. Had any malignancy within 5 years prior to signing the ICF (except for basal cell carcinoma that has received curative treatment and is considered cured)
• •5. Cardiovascular and cerebrovascular diseases, gastrointestinal diseases, diabetes mellitus, medullary thyroid cancer, thyroid C cell hyperplasia, multiple endocrine adenomatosis type 2, chronic pancreatitis, and malignant tumors with obvious clinical significance were present; And any respiratory, neurological, urogenital, hematological, or endocrine disorders that may affect the safety of the subject or the findings of the study
• •6. Patients who have undergone major surgery within 3 months before signing the ICF, or who plan to undergo surgery during the study period
• •7. Known allergy to any component of the investigational drug or prior history of severe drug allergy
• •8. Drugs (including prescription drugs, over-the-counter drugs, Chinese herbs, health products, etc.) that have been used within 3 months before signing the ICF and have been determined by researchers to significantly affect body weight and blood sugar.
• •9. Participated in any clinical trial within 30 days prior to randomization or within 5 half-lives (whichever is older) after the last administration of the investigational drug in the clinical trial (except those who signed ICF and did not receive drug or device intervention)
• •10. Any of the auxiliary test indicators during the screening period meet the following criteria:
• •1. Alanine aminotransferase \>1.5x upper limit of normal (ULN), or ASpartate aminotransferase \>1.5x ULN, alkaline phosphatase \>1.5x ULN, or total bilirubin \>1.5x ULN (subjects with Gilbert's syndrome can participate in this study if direct bilirubin ≤ULN);
• •2. calcitonin ≥50 ng/L;
• •3. Blood amylase or lipase \>ULN;
• •4. Thyroid stimulating hormone \>6.0 mIU/L or \<0.4 mIU/L;
• •5. Hemoglobin a1C (HbA1c) ≥6.0%; Fasting blood glucose ≥6.1 mmol/L or \< 3.9 mmol/L; Or OGTT 2 h blood glucose ≥7.8 mmol/L;
• •6. eGFR \< 60 mL/min/1.73m2;
• •7. Male QTcF\>450 ms, female QTcF\>470 ms
• •11. People tested positive for infectious diseases 12 Habitual smokers, alcoholics and drug abusers;
• •13\. Pregnant or lactating women 14. Blood donors within 3 months prior to randomization 15. In the Investigator's opinion, the subject is not suitable to participate in any other circumstances of the trial