A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B

Exclusion Criteria

• •1. Participants with a history of allergy to the any ingredient or excipients of the drug under study；
• •2. Patients who cannot tolerate venous blood collection and have a history of needle fainting or blood fainting；
• •3. Patients with major trauma or major surgery within 3 months before screening; or plan to have surgery during the study；
• •4. Blood donation or blood loss ≥400 mL within 3 months prior to screening, or received blood transfusion; or blood donation or blood loss ≥200 mL within 1 month prior to screening；
• •5. A history of alcohol or drug abuse or dependence；
• •6. Participants have participated in clinical trials of drugs or medical devices (except in vitro diagnostic reagents) within 3 months prior to administration；
• •7. Use of any hepatitis B drug other than NUC within 1 year prior to administration；
• •8. Participants with systemic use of immunosuppressants, immunomodulators (excluding interferon) and cytotoxic drugs within 6 months before screening; Or those who received live attenuated vaccine within 1 month before screening；
• •9. Participants with clinically significant acute or chronic liver disease caused by non-HBV infection who were judged by the investigator to be unsuitable for the study；
• •10. Participants with a history of cirrhosis (e.g., the subject had a histopathological examination of the liver and reported cirrhosis, or had an endoscopic examination indicating varicose esophagus and fundus veins);
• •11. Participants with hepatitis B cirrhosis in the confirmed or suspected decompensated stage, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, esophageal and fundus variceal bleeding, spleen enlargement, ascites, primary liver cancer, etc；
• •12. Participants with malignancy or history of other malignancies within 5 years prior to screening (except cured basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix)；
• •13. The investigators determined the presence of impaired gastrointestinal function or gastrointestinal disease that might affect oral drug absorption, such as severe gastrointestinal disease (peptic ulcer, erosive or atrophic gastritis), partial gastrectomy, and gastrointestinal symptoms \> grade 2 at the time of screening (e.g., nausea, vomiting, or diarrhea)；
• •14. Participants with suspected or confirmed acute infections within 2 weeks prior to randomization；
• •15. Laboratory examination: platelet count \< 90 x 10\^9 / L; White blood cell count \<3.0 x 10\^9 / L; Neutrophils absolute value\< 1.3 x 10\^9 / L; Serum total bilirubin \>2 x ULN. Albumin\< 30 g/L; Creatinine clearance ≤ 60 mL/min or less; Prothrombin time international standardization ratio (INR) \>1.5；
• •16. Serum AFP (AFP) is greater than 50 ㎍ / L (or 50 ng/mL) or imaging suggest possible malignant liver placeholder；
• •17. Hepatitis C antibody positive, treponema pallidum antibody positive and rapid plasma reagin test (RPR) positive,AIDS antigen/antibody positive；
• •18. Breastfeeding women or those who have a positive pregnancy test at screening or baseline；
• •19. The investigator believes that there are other subjects who are not suitable for participating in this trial.