A Phase I Study of Single Subcutaneous Dose of SHR-1894 in Healthy Subjects

Exclusion Criteria14

• Subjects with a history or current diagnosis of any clinically significant disease, as determined by the investigator, involving the urinary, circulatory, endocrine, neurological, digestive, respiratory, hematopoietic, immune systems, or psychiatric and metabolic disorders.
• Subjects who, in the investigator's judgment, have any condition or disease that may affect the absorption, metabolism, and/or excretion of the investigational drug.
• Subjects who have experienced severe infection, severe trauma, or undergone major surgery within 1 month prior to the screening period; or who plan to undergo surgery during the trial period.
• Subjects with a known allergy to the investigational drug or any of its components, or with a history of atopy (e.g., asthma, eczema).
• Subjects will be excluded if they meet any of the following criteria: Use of any medication (including prescription drugs, over-the-counter medications, Chinese herbal medicines, dietary supplements, and vitamin A and its derivatives, with the exception of other routine vitamins and occasional use of acetaminophen) within 2 weeks prior to screening.Any medication taken within 5 half-lives prior to screening (whichever period is longer).Planned use of any non-study medication during the trial period.
• Subjects will be excluded for any of the following: Participation in any other drug or medical device clinical trial within 3 months prior to screening or planned participation during the study period.Any prior investigational drug taken within 5 half-lives prior to screening (whichever washout period is longer).
• Female subjects who are pregnant, breastfeeding, or have a positive pregnancy test result at screening or baseline.
• Subjects with a history of blood donation (≥ 400 mL) or significant blood loss within 8 weeks prior to screening, or who received a blood transfusion within 4 weeks prior to screening or baseline; or who intend to donate blood during the trial period.
• Subjects who have received any vaccination within 2 weeks prior to screening or who plan to receive any vaccination during the trial.
• Subjects with a history of significant smoking (averaging \>5 cigarettes per day) within 4 weeks prior to screening, or who are unable to abstain from using any tobacco products during the trial period.
• Subjects meeting any of the following criteria will be excluded: Average daily alcohol intake exceeding 15 g (equivalent to 450 mL of beer, 150 mL of wine, or approximately 50 mL of low-alcohol spirits) within 4 weeks prior to screening.Inability to abstain from alcohol consumption during the trial period.A positive alcohol breath test at baseline.
• Subjects with a history of illicit drug use or substance abuse/dependence prior to screening; or a positive urine drug test at baseline.
• Subjects with special dietary requirements that prevent compliance with the standardized diet.
• Subjects with difficult venous access or whose physical condition cannot tolerate frequent blood sampling.