Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants with CHB with Low Viral Load

Launched by AUSPER BIOPHARMA CO., LTD. · Feb 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AHB-137 for people with Chronic Hepatitis B (CHB) who have not been treated before and have a low viral load. The trial will include about 60 participants who will be randomly divided into two groups based on their HBsAg levels, which indicate how much virus is present in their blood. Each participant will go through a screening process that lasts up to 28 days, followed by a 16-week treatment period, and then a 24-week follow-up, making the total duration of participation around 44 weeks.

To be eligible for this trial, participants need to be between 18 and 65 years old, weigh over 50 kg, and have specific levels of the virus in their blood without having received previous antiviral treatments. They should also be in generally good health, without significant liver diseases or infections. During the trial, participants will be closely monitored for the safety and effectiveness of the treatment. It's important for those considering participation to understand that they will be part of a research study aimed at finding better ways to manage Chronic Hepatitis B.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
• • 2. Male or female participants aged 18-65 years old (including the boundary value) at the time of signing the ICF;
• • 3. Male participants weighed higher than 50kg and female participants weighted higher than 50 kg, Body Mass Index (BMI) between 18 to 32 kg/m\^2(inclusive);
• • 4. Participants with positive HBsAg or HBV DNA greater than or equal to (≥) 6 months prior to screening and has not received antiviral treatment with interferon or nucleos(t)ide analogue ;
• • 5. At screening, 20 IU/mL\<HBV DNA≤2000 IU/mL;
• • 6. At screening, 100 IU/mL\<HBsAg≤10000 IU/mL;
• • 7. At screening, ALT\<3×upper limit of normal (ULN);
• • 8. For women with childbearing potential should be non-pregnant or non-lactating during screening, and participants are willing to take effective contraceptive measures from the screening until the last visit or at least 6 months after the last dosing.
• Exclusion Criteria:
• • 1. Clinically significant abnormalities except chronic HBV infection;
• • 2. Any clinically significant liver diseases, including but not limited to hepatitis caused by other pathogenic infections, hemochromatosis, Wilson disease, primary biliary cirrhosis, autoimmune liver diseases, alcoholic liver disease, severe non-alcoholic fatty liver disease, Imaging-diagnosed moderate to severe fatty liver, drug-induced liver injury, history of hereditary liver disease, etc.;
• • 3. Participants with severe infection requiring systemic anti-infection treatment 1 month before randomization;
• • 4. Co-infection with current or past history of Hepatitis C virus (HCV), Human immunodeficiency virus (HIV), Hepatitis D virus (HDV).
• • 5. Participants who have had or currently have cirrhosis or currently have progressive liver fibrosis;
• • 6. Participants who have had or currently have hepatobiliary system tumor; Or blood alpha-fetoprotein (AFP) ≥ 20 ng/mL during screening, or the liver B-ultrasound, CT, MRI and other imaging examinations suggested the possibility of hepatobiliary system tumors;
• • 7. The laboratory examination results are obviously abnormal;
• • 8. History of vasculitis or signs and symptoms of potential vasculitis;
• • 9. Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening.
• • 10. History of extrahepatic disease that may be related to HBV immune status;
• • 11. Administration of immunosuppressants within 3 months prior to screening, except for short-term use (≤2 weeks) or topical/inhaled steroids. Administration of immunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the first study intervention or have a history of vaccination within 1 month prior to screening or planned administration during the study;
• • 12. History of malignancy within the past 5 years or the discovery of suspected tumors during the screening period;
• • 13. Any suspicion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
• • 14. Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study;
• • 15. Blood donation or blood loss more than 400 mL within 12 weeks before screening; Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 month before screening;
• • 16. Concurrently participating in another clinical study, or received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the study treatment or 90 days, whichever is longer;
• • 17. Participants who have received any oligonucleotide or small molecule interfering ribonucleic acid (siRNA) drugs;
• • 18. Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.