A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B

Exclusion Criteria

• •Pregnant and lactating women;
• •Chronic diseases other than chronic HBV infection with significant clinical significance that have a history of mental illness or are deemed unsuitable by researchers for participation in this study;
• •Acute diseases with significant clinical significance occurring within 7 days prior to receiving the investigational drug;
• •Individuals with a history of active pathological bleeding or a tendency towards bleeding;
• •Prescription medication has been used within 14 days prior to receiving the study drug;
• •Receive any preventive or attenuated vaccines within 14 days prior to receiving the study drug;
• •Blood donors or those who have lost a significant amount of blood within the first 3 months of screening, or those who have donated blood during the planned study period;
• •Subjects with a history of excessive alcohol consumption;
• •A history of alcohol or drug abuse within the 12 months prior to screening, or a positive drug screening result during screening;
• •Complicated with other infected disease;
• •Patients with significant liver fibrosis or cirrhosis before or during screening;
• •History of chronic liver diseases other than chronic HBV infection;
• •Patients have a history of hepatocellular carcinoma (HCC) before or at the time of screening, or may be at risk for HCC;
• •Used immunosuppressive or immunomodulatory drugs and cytotoxic drugs within 6 months prior to the study medication;
• •During screening, subjects showed significant laboratory results abnormalities；
• •Screening for tumors with a history of malignancy within the first 5 years, excluding tumors that can be completely cured through surgical resection;
• •Uncontrollable chronic diseases;
• •History of intolerance to subcutaneous injection;
• •Participated in clinical studies of any drug or medical device within 3 months prior to drug administration or within 5 times the half-life of the investigational drug, or used the investigational drug;
• •Those considered unsuitable for enrollment by the investigators.