Chronic Hepatitis B
Conditions
Keywords
Hepatitis B, Chronic
Brief summary
AB-10-8005 is a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with CHB treated with nucleos (t) ide analogues.
Detailed description
The study is to evaluate the antiviral activity and immune response of AHB-137 injection in participants with CHB treated with nucleos(t)ide analogues. The study is proposed to enroll 20-30 patients, with a total study duration of approximately 56 weeks per participants, including a screening period (up to 4 weeks), a clinical study lead-in period (approximately 4 weeks), an AHB-137 treatment period (24 weeks) and a follow-up period (24 weeks).
Interventions
DRUGAHB-137
AHB-137 300 mg will be injected subcutaneously once a week (total 24 weeks).
Sponsors
Ausper Biopharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Voluntarily participated in the study and signed an informed consent form; * Aged between 18 and 55 years at the time of signing the informed consent form; * Body mass index (BMI) within the range of 18-30 kg/ m2; * HBeAg negative or positive at screening; * HBsAg or HBV DNA positive for at least 6 months; * Have been on continuous nucleos(t)ide analogues antiviral therapy for more than 6 months prior to screening; * 100 IU/mL \< HBsAg ≤ 3000 IU/mL and HBV DNA \< 100 IU/mL at screening; * Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN); * Effective contraception as required.
Exclusion criteria
* Clinically significant abnormalities other than a history of CHB infection; * Concomitant clinically significant other liver diseases; * Any serious infection other than CHB infection requiring intravenous anti-infective therapy within 1 month prior to screening; * Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive; * Liver stiffness value (LSM) \> 9.0 kPa at screening; * Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein (AFP) concentration ≥ 20 ng/mL at screening; * Participants with confirmed or suspected hepatic decompensated hepatitis B cirrhosis; * Liver biopsy at screening assessed severity of activity ≥ G3 grade and/or fibrosis reaching S4 stage; * History of extrahepatic disease possibly related to HBV immune status; * Ongoing or taking any immunosuppressive medication within 3 months prior to screening. Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose, or have a history of vaccination within 1 month prior to screening or have a live vaccination plan during the trial; Continuous use of traditional Chinese medicine for more than 2 months within 1 year prior to screening, or within 1 month prior to screening; Ongoing use of anticoagulants, bleeding tendency or coagulopathy, or conditions that, in the opinion of the investigator, increase the risk of liver biopsy; * Receiving or using any interferon-containing therapy within 12 months prior to screening; * History of malignancy within 5 years prior to screening or being evaluated for possible malignancy; * Suspected history of allergy to any component of the study drug, or allergic constitution (multiple drug and food allergy, and judged by the investigator to be clinically significant); * Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study; * Donation or blood loss ≥ 400 mL, or received blood transfusion within 12 weeks prior to screening; Or blood donation or blood loss ≥ 200 mL within 1 month prior to screening; * Participants who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study; * Received any antisense oligonucleotides (ASO) or using any small molecule interfering ribonucleic acid (siRNA) drug within 12 months prior to screening; * Participants with abnormal thyroid function judged by the investigator to be ineligible for enrollment; * Obviously abnormal laboratory test results; * History of vasculitis or signs and symptoms of underlying vasculitis; * Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with serum HBsAg < limit of detection (LOD) 0.05 international unit per milliliter (IU/mL) and Hepatitis B Virus (HBV) DNA < lower limit of quantification (LLOQ) with or without HBsAb seroconversion. | Up to 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants maintaining sustained response; | Up to 48 weeks | — |
| The changes of liver HBsAg, HBcAg, HBV RNA, integration HBV DNA and covalently closed circular DNA (cccDNA) compared to baseline; | Up to 48 weeks | — |
| The changes in the phenotype of liver immune cells compared to baseline; | Up to 48 weeks | — |
| The changes of peripheral blood cytokines compared to baseline; | Up to 48 weeks | — |
| The changes of peripheral blood immune cell phenotypes compared to baseline; | Up to 48 weeks | — |
| The changes of serum HBsAg, HBsAb, HBV DNA, HBV RNA, HBeAg, HBeAb compared to baseline; | Up to 48 weeks | — |
| Number and percentage of participants with serum HBsAg < LOD and/or HBV DNA < LLOQ. | Up to 48 weeks | — |
| The changes in peripheral blood proteomics compared to baseline; | Up to 48 weeks | — |
| The changes in liver metabolomics compared to baseline, if applicable ; | Up to 48 weeks | — |
| AHB-137 drug concentrations, and metabolite profiling, if applicable; | Up to 48 weeks | — |
| Number and percentage of participants with detectable anti-drug antibodies (ADA); | Up to 48 weeks | — |
| Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results. | Up to 48 weeks | Examination including laboratory examination, electrocardiogram (ECG) examination. |
| The changes in peripheral blood metabolomics compared to baseline; | Up to 48 weeks | — |
Countries
China
Contacts
Primary ContactBella Lu
Outcome results
None listed