Hepatitis B, Chronic (CHB)
Conditions
Brief summary
The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB)
Interventions
Subcutaneous injection
Sponsors
Ausper Biopharma Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Able to fully understand and sign the informed consent form (ICF). * Male or female participants, aged 18-65 years (inclusive). * Body mass index (BMI) meeting the predefined eligibility range. * Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening. * At screening, participants meeting predefined ranges of HBsAg, HBV DNA, and ALT according to prior nucleos(t)ide analogue (NA) treatment history (stable prior treatment or treatment-naive), and meeting corresponding prior antiviral treatment duration requirements. * Adopt effective contraceptive measures as required
Exclusion criteria
* History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject unsuitable for study participation. * Prior history of solid organ or hematopoietic stem cell transplantation. * History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential immune activation risk. * History or presence of hepatic decompensation at screening. * History of primary liver cancer, or diagnosis/suspected liver cancer at screening. * Imaging or histological evidence of significant liver fibrosis or cirrhosis within 12 months prior to screening, or a liver stiffness measurement indicative of significant fibrosis or cirrhosis at screening. Major trauma or major surgery within 12 weeks prior to screening * History of severe allergies (e.g., to ≥2 allergens) or severe allergy to any component of the study drug, or in the opinion of the investigator, makes the subject unsuitable for participation. * Severe infection requiring intravenous anti-infective therapy within 2 weeks prior to screening (excluding chronic HBV infection). * History of drug abuse, or alcoholism. * Blood donation or blood loss exceeding the specified volume within 12 weeks prior to screening, or planned blood donation during the trial period. * Use of immunosuppressants, immunomodulators, cytotoxic drugs, or biologics within 6 months prior to screening. * Use of any oligonucleotide drugs or interferon therapy within 12 months prior to screening. * Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period. * Presence of tattoos, active skin diseases, or other conditions that may interfere with subcutaneous drug administration or observation of injection site reactions. * Clinically significant abnormal electrocardiogram (ECG) at screening. * Tested positive for HIV，HCV or active syphilis infection. * Uncontrolled hypertension at screening. * Clinically significant abnormal laboratory test as specified in protocol at screening. * Currently participating in another clinical trials, or within the washout period. * Any other condition or factor which, in the opinion of the investigator, makes the subject unsuitable for trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL) | Up to 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) | Up to 90 days | — |
| Change of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit | Up to 90 days | — |
| Proportion of participants with HBsAg decline from baseline of <0.5, ≥0.5, ≥1.0, ≥1.5, ≥2.0, ≥3.0 log₁₀ IU/mL at each visi | Up to 90 days | — |
| Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit | Up to 90 days | — |
| Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit | Up to 90 days | — |
| Proportion of participants with HBV DNA < LLOQ (10 IU/mL) at each visit | Up to 90 days | — |
| Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) at each visit | Up to 90 days | — |
| Proportion of participants with anti-HBs seroconversion (HBsAg clearance and HBsAb >10 IU/L) at each visit | Up to 90 days | — |
| Absolute or log change from baseline for HBsAg at each visit | Up to 90 days | — |
| Absolute or log change from baseline for HBV RNA at each visit | Up to 90 days | — |
| Absolute or log change from baseline for HBcrAg at each visit | Up to 90 days | — |
| Absolute or log change from baseline for HBeAg at each visit | Up to 90 days | — |
| Absolute or log change from baseline for HBeAb at each visit | Up to 90 days | — |
| Proportion of participants with baseline ALT > ULN achieving ALT normalization, and time to ALT normalization | Up to 90 days | — |
| Incidence and severity of treatment-emergent adverse events (TEAE) and serious adverse events (SAE) | Up to 90 days | CTCAE will be used to describe severity. |
| Proportion of participants with clinically significant abnormalities in laboratory tests | Up to 90 days | — |
| Proportion of participants with clinically significant abnormalities in ECG | Up to 90 days | — |
| Proportion of participants with clinically significant abnormalities in physical examinations and vital signs | Up to 90 days | — |
| Changes in ECG from baseline | Up to 90 days | — |
| Proportion of participants with HBsAg decline ≥2.0 log₁₀ IU/mL | Up to 90 days | — |
| Plasma concentration of AHB-171 at different time points | Up to 90 days | — |
| Proportion of participants with detectable anti-drug antibody (ADA) | Up to 90 days | — |
Countries
China
Contacts
CONTACTBella Lu
Outcome results
None listed