A Study of RBD1016 in CHB Participants

The study consists of screening period, treatment period, and FU period. It is divided into 3 dose groups, namely 100 mg Q4W, 200 mg Q4W and 200 mg Q12W. Each group will enroll 16 eligible participants, with 12 participants receiving RBD1016 injection and 4 participants receiving placebo.

Inclusion criteria

• Willing and able to give written informed consent for study participation;
• Male or female participants aged 18-65 years;
• Body mass index (BMI) within the range of 18-34 kilograms/square meter (kg/m2);
• Documented history of chronic hepatitis B virus (HBV) infection, by positive HBsAg and/or HBV DNA tests ≥ 6 months before screening;
• HBeAg positive or negative at screening;
• On a stable regimen (≥ 12 months before screening) of any approved first-line oral NAs;
• HBV DNA level <100 IU/mL at screening;
• HBsAg level ≥50 IU/mL at screening;
• Serum alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal (ULN);
• Liver transient elastography (FibroScan) results within 12 months before screening or at screening showing that the liver stiffness measurement (LSM) level is less than 9 kPa; or with liver biopsy within 24 months before screening showing that the Metavir score is F0-F2;

Exclusion criteria

• Diagnosed with other liver diseases other than hepatitis B;
• History of liver cirrhosis or hepatic decompensation (e.g., ascites, varices bleeding, or hepatic encephalopathy) before or at screening;
• History of organ transplantation or previous or concurrent with hepatocellular carcinoma (HCC), or imaging findings suggesting a possibility of malignant liver lesions;
• Concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV), or diagnosis of syphilis, acute hepatitis A or acute hepatitis E;
• Laboratory results at screening as follows: serum alpha-fetoprotein (AFP) >50 μg/L; serum albumin concentration <3.0 g/dL; international normalized ratio (INR) >1.5; platelet count <90×10^9/L; serum direct bilirubin (DB) >2×ULN; serum creatinine concentration >1.5×ULN or creatinine clearance <60 mL/min (according to the Cockcroft-Gault equation); or any clinically significant laboratory outliers that the investigator believes may interfere with the interpretation of the efficacy and safety data in this study;
• Those who the investigator believes are not suitable to participate in the study due to other factors.