Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB)

Phase 2

Active, not recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: AHB-137; Drug: Placebo; Drug: NAs

• Registration Number: NCT06829329
• Lead Sponsor: Ausper Biopharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-13
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-17
• Last Update Submitted: 2025-09-22
• Last Update Posted: 2025-09-24
• Primary Completion: 2025-10-21
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AHB-137 and placebo	AHB-137	-
AHB-137 and placebo	Placebo	-
AHB-137 and Nucleos(t)Ide Analogue (NAs)	AHB-137	-
AHB-137 and Nucleos(t)Ide Analogue (NAs)	NAs	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of participants achieving functional cure during 24 weeks after discontinuation of all CHB therapy.	Up to 48 weeks
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
Time of ALT normalization in absence of rescue therapy	Up to 48 weeks	Only for participants with abnormal ALT at baseline
Proportion of participants with ALT normailzation in absence of rescue therapy.	Up to 48 weeks	Only for participants with abnormal ALT at baseline
The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma	Up to 48 weeks
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: Area under the concentration-time curve (AUC) of AHB-137	Up to 48 weeks
Plasma concentrations of AHB-137	Up to 48 weeks

Trial Locations

Locations (4)

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing Municipality, China

Mengchao Hepatobiliary Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

The Third People's Hospital of Zhenjiang; 🇨🇳 Zhenjiang, Jiangsu, China

The First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China