A Study of RBD1016 in CHB Participants

Overview

This study consists of Part A and Part B. Part A is a multi-center, randomized, double-blind, placebo-controlled clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection combined with NAs in CHB participants. Part B is a multi-center, open clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection combined with PegIFN-α and NAs in CHB participants.

Description

The study consists of screening period, treatment period, and follow up period. Part A is divided into 3 dose groups, namely 100 mg Q4W, 200 mg Q4W and 200 mg Q12W. Each group will enroll 28 eligible participants, with 21 participants receiving RBD1016 injection and 7 participants receiving placebo. Part B has a RBD1016 200mg dose group, which will enroll 20 participants to receive RBD1016 combined with PegIFN-α and NAs treatment.

Eligibility

Inclusion Criteria:

1. Willing and able to give written informed consent for study participation;
2. Male or female participants aged 18-65 years;
3. Body mass index (BMI) within the range of 18-34 kilograms/square meter (kg/m2);
4. Documented history of chronic hepatitis B virus (HBV) infection, by positive HBsAg and/or HBV DNA tests ≥ 6 months before screening;
5. HBeAg positive or negative at screening;
6. On a stable regimen (≥ 12 months before screening) of any approved first-line oral NAs;
7. Serum alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal (ULN);
8. 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:

1. Diagnosed with other liver diseases other than hepatitis B;
2. History of liver cirrhosis or hepatic decompensation (e.g., ascites, varices bleeding, or hepatic encephalopathy) before or at screening;
3. History of organ transplantation or previous or concurrent with hepatocellular carcinoma (HCC), or imaging findings suggesting a possibility of malignant liver lesions;
4. Concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV), or diagnosis of syphilis, acute hepatitis A or acute hepatitis E;
5. 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;
6. Those who the investigator believes are not suitable to participate in the study due to other factors.

Additional exclusion criteria for Part B:

1. Participants who are judged not to be suitable for IFN treatment for any reason;
2. History of IFN treatment within 12 months prior to screening;
3. Other situations that the investigator believes are not suitable to participate in Part B.