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

Inclusion criteria

• Subjects voluntarily participate in this study and sign informed consent;
• Male and female ≥18 years old and ≤65 years old;
• Male subjects with a weight of ≥ 50 kilograms and female subjects with a weight of ≥ 45 kilograms, BMI 18~28 kg/m2;
• Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more than 6 months and HBeAg positive ; During the screening period, 100 IU/ml ≤ HBsAg quantification ≤ 5000 IU/ml;
• The subjects are able to communicate well with the researchers, voluntarily and can understand and follow the experimental protocol process to complete the study;
• The subjects (including partners) are willing to voluntarily adopt effective contraceptive measures during the clinical trial period and long-term follow-up period, and specific contraceptive measures are shown in the appendix;
• The treated patients need to meet the condition:The subject must have received oral nucleoside (acid) drug treatment and a stable treatment regimen;
• Newly treated patients must meet the condition:During screening, the subjects had never received antiviral treatment for chronic hepatitis B B (oral nucleoside (acid) drugs and interferon), or had irregular antiviral treatment in the past, but had not received any antiviral treatment for chronic hepatitis B 3 months before enrollment.

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.