Chronic hepatitis B
Conditions
Interventions
The 200mg dose group for the initial treatment of chronic hepatitis B:AHB-171 Injection
Adaptive-dose group for the initial treatment of chronic hepatitis B:AHB-171 Injection
Adaptive dose group of nucleoside (acid) analogues for the treatment of chronic hepatitis B:AHB-171 Injection
Nucleoside (acid) analogues treated chronic hepatitis B 200mg dose group:AHB-171 Injection
Nucleoside (acid) analogues treated chronic hepatitis B 100mg dose group:AHB-171 Injection
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Those who voluntarily participate in this trial, understand the content and sign the informed consent form before participating in any research procedures of this trial; and agree to complete the trial procedures as required by the trial protocol. 2. The age at signing the informed consent form is between 18 and 65 years old (inclusive of 18 and 65), male or female. 3. Male participants have a body weight of no less than 50 kilograms, and female participants have a body weight of no less than 45 kilograms. The body mass index (BMI) is within the range of 18-32 kg/m^2 [including the critical value, BMI = weight (kg) / height^2 (m^2)]. 4. CHB participants with positive HBsAg or HBV DNA at the screening stage for at least 6 months. 5. For the NA treatment participant cohort: a) Screening with negative HBeAg; b) Screening with HBsAg > 100 IU/mL and 100 IU/mL and < 10,000 IU/mL; b) Screening with HBV DNA < 10,000 IU/mL; c) Screening with ALT <= 3 × ULN; d) Screening with no NA treatment for at least 12 months. 7. For fertile female participants, the serum pregnancy test result during the screening period must be negative (women with permanent contraception or natural menopause for 1 year or more are considered to have no fertility and do not need to undergo this test). 8. Fertile female participants and fertile male partners (including partners) are willing to take effective contraceptive measures from the screening stage to 6 months after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. In addition to a history of chronic HBV infection, having other serious diseases, including but not limited to neurological, cardiovascular, hematological and lymphatic system, immune system, kidney, thyroid, gastrointestinal, respiratory, metabolic and skeletal system diseases, as well as a history of malignant tumors, and those determined by the investigator to potentially affect their safety or the results of the study; 2. Those who have previously undergone solid organ transplantation or hematopoietic stem cell transplantation; 3. Those with other liver diseases, such as hepatitis caused by other pathogens, hemochromatosis, Wilson's disease (hepatolenticular degeneration), primary biliary cholangitis, autoimmune liver diseases, alcoholic liver diseases, drug-induced liver injury and severe non-alcoholic fatty liver disease, and those considered unsuitable to participate in this clinical trial by the investigator; 4. Those with autoimmune diseases or diseases with the risk of immune activation, including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, scleroderma, multiple sclerosis, moderate to severe psoriasis, idiopathic thrombocytopenic purpura or autoimmune hemolytic anemia or a history of vasculitis; 5. Those who have clinical evidence of liver dysfunction deterioration in the past (including but not limited to esophageal or gastric varices, gastrointestinal bleeding, ascites or hepatic encephalopathy); 6. Those who have a history of primary hepatocellular carcinoma (HCC); or who were diagnosed with or suspected of having HCC during screening; or those whose alpha-fetoprotein (AFP) was >= 20 ng/mL during screening; 7. Those who had pathological or imaging evidence of significant liver fibrosis or cirrhosis within 12 months before screening, or those whose liver stiffness value (LSM) detected by FibroScan® or equivalent equipment was > 8.0 kPa in NA-treatment participants, or LSM > 9.0 kPa in initial treatment participants before screening; 8. Those who had major trauma or major surgery within 12 weeks before screening and had not fully recovered, or those with a surgical plan during the study; 9. Those with severe allergic constitution (allergic to more than two drugs or foods), or those with a suspected severe allergic history to any component of IP, and those determined by the investigator to be unsuitable to participate; 10. Those who had a serious infection (except chronic HBV infection) within 2 weeks before screening and required intravenous anti-infection treatment; 11. Those with a history of drug use or drug abuse, and/or alcohol abuse (meeting the criteria of consuming 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine; or determined by the investigator to potentially interfere with the participant's compliance or safety); 12. Those who donated blood or lost blood >= 400 mL in the past 12 weeks or had a blood donation plan during the study; 13. Those who received immunosuppressants, immunomodulators, cytotoxic drugs or biological agents within 6 months before screening (excluding short-term courses or local/inhalation medications of <= 2 weeks); 14. Those who received any oligonucleotide drugs (ASO or siRNA) or interferon treatment within 12 months before screening; 15. Those who received vaccines (except influenza and COVID-19 vaccines) within 4 weeks before screening or had a vaccination plan during the trial; 16. Those with abnormal skin conditio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy evaluation endpoint indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Immunogenicity Endpoints;Pharmacokinetic Endpoints; | — |
Countries
China
Contacts
Public ContactJunqi Niu;Yanhang Gao
The First Hospital of Jilin University
Outcome results
None listed