Chronic Hepatitis B
Conditions
Keywords
Hepatitis B, Chronic
Brief summary
The study is to evaluate the efficacy and safety of AHB-137 in CHB participants. The total duration of the study, including screening phase, treatment phase and follow-up phase.
Interventions
Sponsors
Ausper Biopharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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; * Male or female participants aged 18-65 years old (including the boundary value) at the time of signing the ICF; * Male participants weighed higher than 50 kg and female participants weighted higher than 50 kg, Body Mass Index (BMI) between 18 to 32 kg/m\^2(inclusive); * 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 NAs ; * At screening, ALT\<3×upper limit of normal (ULN); * Use effective contraception as required; * HBV DNA within the specified range at screening; * HBsAg was within the specified range at screening.
Exclusion criteria
* Clinically significant abnormalities except chronic HBV infection; * Any clinically significant liver diseases; * Participants with severe infection requiring systemic anti-infection treatment 1 month before enrollment; * Active hepatitis C, HIV antibody positive, treponema pallidum antibody positive; * Hepatobiliary neoplasm malignant; * The laboratory examination results are obviously abnormal; * History of vasculitis or signs and symptoms of potential vasculitis; * Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening. * History of extrahepatic disease that may be related to HBV immune status; * 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; * History of malignancy within the past 5 years or the discovery of suspected tumors during the screening period; * 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; * Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study; * 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; * Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study; * Participants who have received any oligonucleotide or small molecule interfering ribonucleic acid (siRNA) drugs; * Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ). | Up to 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HBsAg<LOD (0.05 IU/mL) and the percentage of participants with different levels of HBsAg reduction compared with baseline. | Up to 48 weeks | — |
| Number of participants with HBV DNA<LLOQ and the percentage of participants with different HBV DNA reduction. | Up to 48 weeks | — |
| Proportion of participants achieving HBsAg<LOD and HBV DNA<LLOQ, with or without HBsAb | Up to 48 weeks | — |
| Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb | Up to 48weeks | — |
| Changes of the score of hepatitis B quality of life instrument (HBQOL) compared with baseline | Up to 48 weeks | The HBQOL consists of 31 items covering 7 dimensions: psychological well-being, anticipation anxiety, vitality, stigma, transmissibility, vulnerability and virus response. Response options range from 1 to 5 with higher scores indicating more severe impact of Hepatitis B than lower scores. |
| Percentage of participants who reached HBeAg negative | Up to 48 weeks | Only for participants with HBeAg positive at baseline |
| Percentage of participants achieving HBeAg seroconversion | Up to 48 weeks | Only for participants with HBeAg positive at baseline |
| Proportion of participants achieving functional cure during 24 weeks after discontinuation of all CHB therapy. | Up to 48 weeks | — |
| Time of ALT normalization in absence of rescue therapy | Up to 48 weeks | Only for participants with abnormal ALT at baseline |
| Safety: number of participants with treatment-emergent adverse events (TEAEs), treatment-related adverse events(TRAEs), serious adverse events (SAE) and clinically significant examination results | Up to 48 weeks | Examination including laboratory examination, electrocardiogram (ECG) examination |
| Immunogenicity: number and percentage of participants with detectable anti-drug antibodies (ADA) | Up to 48 weeks | — |
| The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma | Up to 48 weeks | — |
| The pharmacokinetic profile of AHB-137: Area under the concentration-time curve (AUC) of AHB-137 | Up to 48 weeks | — |
| Plasma concentrations of AHB-137 | Up to 48 weeks | — |
| Proportion of participants with ALT normailzation in absence of rescue therapy. | Up to 48 weeks | Only for participants with abnormal ALT at baseline |
Countries
China
Outcome results
None listed