Safety, Tolerability and Pharmacokinetic Studies of HRS-2183 for Injection in Healthy Chinese Subjects After Single and Multiple Administration

Exclusion Criteria17

• History of significant allergies to any food or drug, especially to the investigational product, its components, or drugs of a similar class.
• History or current presence of any clinically significant disease in major organ systems (e.g., cardiovascular, hepatic, renal, neurological, etc.).
• Any clinically significant abnormalities found during screening assessments (including physical examination, vital signs, and laboratory tests).
• Clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening.
• Evidence of impaired renal function based on laboratory tests (e.g., eGFR, serum creatinine).
• Positive screening for specified infectious diseases (e.g., HIV, HBV, HCV, Syphilis).
• Use of any medication (including prescription, OTC, and herbal) within a specified period before the study.
• Excessive consumption of certain beverages (e.g., caffeine, grapefruit juice) or inability to adhere to dietary restrictions.
• History of major surgery within the past 3 months or planned surgery during the study period.
• Participation in another clinical trial within the past 3 months.
• Significant blood loss, blood donation, or transfusion within the past 3 months.
• History of excessive alcohol consumption or unwillingness to abstain during the study.
• History of heavy smoking or unwillingness to abstain during the study.
• History of drug abuse or positive drug screening test.
• Inability to tolerate venous access or history of fainting during blood draws.
• Inability to comply with the standardized diet provided during the study.
• Any other reason that, in the opinion of the investigator, makes the subject unsuitable for the study.