A Clinical Study of 162 in Subjects With Chronic Hepatitis B Virus Infection

Exclusion Criteria

• •1\. Patients who had history of anaphylaxis against the active ingredients or excipients of the investigational product 162.
• •2\. History of allergic reactions to monoclonal antibodies or antibody fragments.
• •3\. History or presence of clinical significant liver disease other than chronic HBV infection (e.g., autoimmune hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis).
• •4\. Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following: New York Heart Association class III-IV for cardiac insufficiency； Patients with poorly controlled arrhythmia: QTc interval \> 480 ms calculated by Fridericia's formula, or congenital syndrome of prolonged QT interval; Any of the following within 6 months prior to the screening: myocardial infarction, severe or unstable angina, congestive heart failure, cerebrovascular accident (including transient ischemic attack), symptomatic pulmonary embolism or other clinically significant thromboembolic disease, or coronary artery bypass graft; Patients with other clinically significant cardiovascular disease who were assessed as unsuitable for this study by the investigator.
• •5\. Patients with uncontrolled hypertension (systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or previous hypertensive crisis or hypertensive encephalopathy.
• •6\. Patients with other active infections other than HBV infection requiring continual treatment with antibiotics or antivirals (except for clinically insignificant temporary infection such as cold), or positive for hepatitis C virus (HCV) or human immunodeficiency virus (HIV) antibodies at screening.
• •7\. Patients with history of hepatitis A virus (HAV), hepatitis D virus (HDV) or hepatitis E virus (HEV).
• •8\. Patients with history of malignant tumor within 5 years except cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix.
• •9\. History or presence of immune-mediated diseases, including but not limited to idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis.
• •10\. Liver biopsy, Fibroscan or equivalent test obtained within the past 6 months demonstrating liver with evidence of progressive fibrosis or cirrhosis ( Metavir 3, recommended cut-off for fibroscan 8.5 kPa).
• •11\. Evidence of liver cirrhosis or decompensated liver disease such as Child-Pugh Class B or C, ascites, esophageal or gastric varices, hepatic encephalopathy or portal hypertension.
• •12\. History of or suspicion of hepatocellular carcinoma or alpha fetoprotein (AFP) \> 50 ng/mL at screening.
• •13\. History of allogenic transplantation of organs, bone marrow or stem cell. 14. Any other concomitant disease, condition or treatment that could interfere with the conduct of the study or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the subject in the study or interfere with the interpretation of study data.
• •15\. Those who received blood transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to screening 16. Patients who have not sufficient baseline organ function and whose laboratory data meet the following criteria at enrollment: Absolute neutrophil count (ANC) \< 2.0×109/L; Serum albumin \< 35 g/L; Total bilirubin \> 1.5×ULN; International normalized ratio (INR) \> 1×ULN; Hemoglobin \< 100 g/L; Platelets \< 80×109/L; Creatinine clearance \< 50 mL/min. 17. Patients who had received an immunosuppressant, immunity-modifying drug (e.g., interferon, thymosin agents), cytotoxic chemotherapy that can affect their immune system, or radiation therapy within 6 months prior to the dosing of investigational product, except for the following treatments: a) topical or inhaled corticosteroids; b) short-term (treatment duration up to 7 days) use of systemic glucocorticoids for prevention or treatment of non-autoimmune allergic diseases.
• •18\. Those who have received live or attenuated vaccines (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, typhoid vaccine, etc.) within 4 weeks before screening, or any covid-19 vaccine within 2 weeks before screening.
• •19\. Those who underwent major surgery within 4 weeks before screening, or plan to undergo major surgery during the study.
• •20\. Those who are participating in other clinical studies, or currently not participating in a study and have been dosed in another clinical study 4 weeks prior to screening, or previous treatment with an investigational agent for chronic HBV infection 6 months prior to screening.
• •21\. Pregnant or lactating women. 22. Those who are determined disqualified to join clinical studies by investigator for other causes.