Clinical Study to Evaluate the Efficacy and Safety of HH-006 in Patients With Chronic Hepatitis B Virus Infection

Exclusion Criteria

• •Co-infected with hepatitis C, syphilis, or human immunodeficiency virus (HIV);
• •At screening: total bilirubin ≥ 3 × ULN and direct bilirubin (DBil) \> 1 × ULN; hemoglobin \< 100 g/L; platelet count \< 100,000/mm³ (100 × 109/L); absolute neutrophil count \< 1,500/mm³ (1.5 × 109/L); serum albumin \< 35 g/L; prothrombin time international normalized ratio (INR) \> 1.3; glycated hemoglobin (HbA1c) ≥ 7%; estimated glomerular filtration rate (eGFR) (MDRD formula) \< 60 mL/min/1.73 m² (Appendix 2 MDRD calculation formula);
• •Clinically significant electrocardiogram (ECG) abnormalities (e.g., QTcF \> 450 ms in males, \> 470 ms in females, severe arrhythmias such as torsade de pointes, paroxysmal ventricular tachycardia, symptomatic atrial fibrillation/flutter requiring emergency treatment, complete atrioventricular block); poorly controlled or refractory hypertension (e.g., systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg after medication use, etc.);
• •Concurrent clinically significant other liver diseases, including but not limited to: moderate or severe fatty liver, alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, drug-induced liver injury, etc.;
• •History of progressive hepatic fibrosis or cirrhosis at any time prior to or during screening;
• •Current or prior history of hepatic decompensation manifestations, including but not limited to: ascites, hepatic encephalopathy, esophageal and gastric variceal bleeding, hepatorenal syndrome, etc.;
• •Previous history of hepatocellular carcinoma, or at screening: serum alpha-fetoprotein (AFP) ≥ 50 ng/mL; or liver ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) findings suggestive of possible hepatocellular carcinoma;
• •Concurrent severe diseases or clinical conditions in other systems that, in the investigator's judgment, make the participant unsuitable for inclusion in this study:
• •1. Circulatory system diseases: e.g., unstable angina, myocardial infarction, congestive heart failure, etc.;
• •2. Respiratory system diseases: e.g., severe chronic obstructive pulmonary disease, etc.;
• •3. Primary or secondary kidney diseases (e.g., chronic renal decompensation, renal diseases secondary to diabetes, hypertension, vascular diseases, etc.);
• •4. Endocrine system diseases: e.g., poorly controlled diabetes or thyroid diseases, etc.;
• •5. Autoimmune diseases: e.g., systemic lupus erythematosus, primary immune thrombocytopenia, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, autoimmune hemolytic anemia, severe psoriasis, etc.;
• •6. Neuropsychiatric disorders: e.g., epilepsy, schizophrenia, depression, etc.;
• •7. Malignant tumors;
• •Lactating women or those with a positive pregnancy test;
• •Persistent alcohol consumption (average daily intake \> 40 g alcohol for males, \> 20 g alcohol for females) or illicit drug abuse within 6 months prior to screening (including the screening period);
• •Participation in any clinical trial of a drug (except for those who did not receive the investigational product) or medical device (except for non-invasive medical devices) within 3 months prior to screening;
• •Major trauma or major surgery within the past three months;
• •History of allergy to HH-003, HH-006, or polysorbate 80;
• •In the investigator's judgment, unsuitability for participation in this study, or close relationship with the study site: e.g., immediate family members of the investigator, or affiliated personnel (e.g., site staff or students).