SA1211 Injection Phase 1 Study

Inclusion criteria

• Able to correctly understand and sign the informed consent form in writing.
• Male or female participants.

• For healthy participants: aged 18-55 years old (inclusive of the cut-off values).
• For participants with chronic hepatitis B (CHB): aged 18-65 years old (inclusive of the cut-off values).
• Body Mass Index (BMI) meets the following requirements.

• For healthy participants: within the range of 18-28 kg/m² (inclusive of the cut-off values).
• For participants with chronic hepatitis B (CHB): within the range of 18-32 kg/m² (inclusive of the cut-off values).
• During the screening period, the results of the following examinations are either normal or abnormal but not clinically insignificant:

• Clinical laboratory tests: complete blood count, blood biochemistry, coagulation function, urine routine. Thyroid function test. 12-lead electrocardiogram (ECG). Abdominal ultrasound. Posteroanterior chest X-ray.
• For participants with chronic hepatitis B (CHB): documented hepatitis B virus (HBV) infection for at least 6 months before screening, with positive hepatitis B surface antigen (HBsAg) and/or positive HBV deoxyribonucleic acid (HBV DNA).
• For female participants of childbearing potential: must not be pregnant or lactating, and agree to use effective contraception during the study period.
• For male participants of childbearing potential: agree to use effective contraception during the study period to ensure effective contraception for their sexual partners.

Exclusion criteria

• Participants with concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV) or syphilis infection; or those previously diagnosed with hepatitis A, D, or E who have not been cured.
• Participants with severe diseases, including but not limited to diseases of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, thyroid, gastrointestinal, respiratory, metabolic, and skeletal systems, as well as a history of malignant tumors.
• Participants with severe mental illness or uncontrolled mental disorders, including but not limited to schizophrenia, bipolar disorder, or depression.
• Participants with a systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening, who are deemed unsuitable for the study by the investigator.
• Participants who have undergone major surgery within 6 months before screening, or plan to undergo surgery during the study period.
• Participants with severe infection or trauma within 4 weeks before screening.
• Participants with a severe allergic constitution, or a confirmed allergy to this product or its formulation components.
• Participants who smoked more than 5 cigarettes per day or the equivalent amount of tobacco within 3 months before screening.
• Participants deemed unsuitable for the trial by the investigator due to other factors.