Clinical Trials in China / NCT06829329
Active, not recruiting
Phase 2
Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB)
NCT06829329 · tracked via the Priya Life Science China tracker
Condition(s) studied
Chronic Hepatitis B
Investigational drug(s) / intervention(s)
AHB-137: AHB-137 will be administered .
NAs: NAs will be administered.
Placebo: Placebo will be administered .
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | |
| Mengchao Hepatobiliary Hospital of Fujian Medical University | Fuzhou | Fujian | |
| AusperBio Investigational Site | Guangzhou | Guangdong | |
| AusperBio Investigational Site | Changzhou | Jiangsu | |
| The Third People's Hospital of Zhenjiang | Zhenjiang | Jiangsu | |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang |
More Ausper Biopharma Co., Ltd. trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06829329 on ClinicalTrials.gov ↗ ← All trials in China