A Clinical Study of HH-006 in Untreated Chronic Hepatitis B Virus Infected Patients

Prior treatment

• History of or concurrent progressive liver fibrosis or cirrhosis;
• History of or concurrent hepatocellular carcinoma, or at screening: blood alpha-fetoprotein (AFP) ≥ 50 ng/mL; or imaging examinations such as liver ultrasound, CT, or MRI suggest possible hepatocellular carcinoma.
• Concurrent severe diseases of other systems or clinical conditions that, in the investigator's judgment, make the subject unsuitable for participation in this study:
  • Circulatory system diseases: e.g., unstable angina, myocardial infarction, congestive heart failure, etc.
  • Respiratory system diseases: e.g., severe chronic obstructive pulmonary disease (COPD), etc.
  • Primary or secondary renal diseases: e.g., chronic renal decompensation and renal diseases secondary to diabetes, hypertension, vascular diseases, etc.
  • Endocrine system diseases: e.g., poorly controlled diabetes or thyroid disease, etc.
  • Autoimmune diseases: e.g., systemic lupus erythematosus, primary thrombocytopenic purpura, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, autoimmune hemolytic anemia, severe psoriasis, etc.
  • Neuropsychiatric diseases: e.g., epilepsy, schizophrenia, etc. Malignancies.
• History of sustained alcohol consumption (average daily alcohol intake \> 40 g for males, \> 20 g 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 drug) or medical device (except for non-invasive medical devices) within 3 months prior to screening, or being within 5 half-lives of a prior drug at the time of screening.
• Significant trauma or major surgery within 3 months prior to screening.
• Known allergy to antibody-based drugs or to any component of the investigational drug.

Other illness

• Co-infection with hepatitis C, syphilis, or HIV.
• History of alcoholic liver disease, non-alcoholic steatohepatitis, autoimmune liver disease or other hereditary liver diseases, drug-induced liver disease, or other clinically significant chronic liver diseases not caused by HBV.

Lab values

• At screening: total bilirubin \> 1.1 × ULN or direct bilirubin \> 1.1 × ULN; hemoglobin \< 120 g/L (male) or \< 110 g/L (female); platelets \< 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; estimated glomerular filtration rate (eGFR, MDRD formula) \< 60 mL/min/1.73 m².

Other

• Females who are pregnant, breastfeeding, or have a positive pregnancy test at baseline with childbearing potential.
• Clinically significant ECG abnormalities;
• Individuals judged by the investigator to be unsuitable for participation in this study, or those with a close relationship to the study center: e.g., relatives of the investigator, affiliated personnel (e.g., staff or students of the study center).

• Male or female aged 18 to 60 years (inclusive);
• Male weight ≥ 45 kg, female weight ≥ 40 kg, and body mass index (BMI, BMI = weight/height²): 18 kg/m² ≤ BMI ≤ 32 kg/m²;
• HBsAg positive for more than 6 months (including 6 months), and with 100 IU/mL \< HBsAg \< 5000 IU/mL prior to randomization;
• HBV DNA ≥ 100 IU/mL prior to randomization;
• ALT ≤ 5 × ULN prior to randomization;
• No prior interferon antiviral therapy within 1 year before the screening period, and no prior treatment with nucleos(t)ide analogues within 6 months before the screening period;
• Males not having undergone sterilization surgery and females not postmenopausal for less than two years must agree to use adequate and effective contraceptive measures from screening until the last follow-up visit of the study (including hormonal contraceptives, intrauterine devices, cervical caps, or condoms);
• Subjects must understand and comply with the study procedures, participate voluntarily, and sign the informed consent form.