A Trial to Evaluate the Efficacy and Safety of WGc0201 in Patients With Chronic Hepatitis B Virus Infection

Prior treatment

• Includes HIV, co-infection with HDV, and liver biopsy suggestive of cirrhosis or advanced fibrosis within 6 months prior to screening (Metavir activity level A3 and stages F3 and F4; Ishak stages 4-6);
• History of hepatic failure (e.g., ascites, encephalopathy, or variceal bleeding) or prior hepatocellular carcinoma;
• Subjects who have participated in any drug/device clinical study within 3 months prior to receiving the experimental drug.
• Those with alcoholism (alcohol consumption for more than 5 years prior to the screening period, with alcohol content greater than 40g per day for men and 20g per day for women) or known drug dependence.

Other illness

• Diseases or past history of the following systems or serious illnesses that the investigator considers inappropriate for participation in this trial, such as: cardiovascular system: unstable or significant cardiovascular disease, such as angina pectoris, recent episode of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or ECG abnormality, etc.; respiratory system: bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc.; endocrine and metabolic diseases: diabetes mellitus, thyroid disease poorly controlled by medication, etc.; others: autoimmune diseases, active tuberculosis, malignant diseases (e.g., tumors), history of neurological or psychiatric disorders, etc;
• History of organ transplantation (except corneal transplantation and hair transplantation).

Lab values

• If no liver biopsy was documented, a Fibroscan screen result \>9 kPa (or equivalent) or a FibroTest screen result \>0.48 and an APRI (Aspartate Aminotransferase to Platelet Ratio Index) \>1 within ≤6 months of screening.
• Alanine aminotransferase \>3x ULN;
• Albumin \<3.5 g/dl;
• Direct bilirubin \> 1.5x ULN;
• Platelet count \<100,000/μl;

Other

• Internationally standardized ratio \> 1.5;
• Subjects who have a birth plan or a plan to donate sperm or eggs during the screening period, during the trial, and for 6 months after the end of the trial or who are unwilling to use effective contraception.

• Adult males or females aged ≥18 to ≤65 years;
• 18≤ BMI ≤32 kg/m2;
• Diagnosis of chronic hepatitis B infection (HBsAg positive for more than 6 months and detectable at screening);
• Received only nucleoside (acid) analog therapy in the 12 months prior to screening and are still taking it regularly;
• HBV-DNA viral load below 100 IU/ml;
• HBsAg \<1500 IU/ml.