Tests AHB-137 injection against a placebo in adults with chronic hepatitis B
Tests an AHB-137 injection or a placebo in adults with chronic hepatitis B.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B
Key facts
- Where
- Beijing, Changchun, Changsha, Chengdu, Chongqing, Guangzhou, Hangzhou, Jiangmen, Kunming, Liuzhou, Meizhou, Nanchang, Nanjing, Qingyuan, Shanghai, Shenyang, Shenzhen, Wuhan, Xi’an, Xiamen, and Yichang, ChinaSee the 23 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-65 with chronic hepatitis B who have never had antiviral treatment, to test the injection AHB-137 against placebo.
- Age
- 18-65 years
- Sex
- All sexes can join.
- Disease stage
- Chronic hepatitis B (HBsAg or HBV DNA positive for at least 6 months) with ALT below 3xULN. People with significant fibrosis, cirrhosis or liver stiffness above 9.0 kPa cannot join.
- Earlier treatment
- No earlier antiviral treatment with interferon or nucleoside analogue. No earlier antisense oligonucleotide, siRNA or capsid assembly modulator for hepatitis B.
- Biomarker or test result
- HBsAg or HBV DNA positive for at least 6 months, with HBsAg and HBV DNA values that meet the protocol requirements at screening.
Main reasons for not taking part
- Hepatitis C, HIV or syphilis positive at screening
- Significant fibrosis, cirrhosis or liver stiffness above 9.0 kPa
- Other serious liver disease or signs of liver decompensation
- Autoimmune disease or history of vasculitis
- Liver cancer, or other cancer within the past 5 years
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07635186, who can take part
Where in China
- Beijing, Beijing MunicipalityHospital not named in the registryTaking people
- Changchun, JilinHospital not named in the registryTaking people
- Changsha, HunanHospital not named in the registryTaking people
- Chengdu, SichuangHospital not named in the registryTaking people
- Chongqing, Chongqing MunicipalityHospital not named in the registryTaking people
- The Second Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
- Guangzhou, GuangdongHospital not named in the registryTaking people
- Hangzhou, ZhejiangHospital not named in the registryTaking people
- The First Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaTaking people
- Jiangmen, GuangdongHospital not named in the registryTaking people
- Kunming, YunnanHospital not named in the registryTaking people
- Liuzhou, GuangxiHospital not named in the registryTaking people
- Meizhou, GuangdongHospital not named in the registryTaking people
- Nanchang, JiangxiHospital not named in the registryTaking people
- Nanjing, JiangsuHospital not named in the registryTaking people
- Qingyuan, GuangdongHospital not named in the registryTaking people
- Shanghai, Shanghai MunicipalityHospital not named in the registryTaking people
- Shenyang, LiaoningHospital not named in the registryTaking people
- Shenzhen, GuangdongHospital not named in the registryTaking people
- Wuhan, HubeiHospital not named in the registryTaking people
- Xi’an, ShanxiHospital not named in the registryTaking people
- Xiamen, FujianHospital not named in the registryTaking people
- Yichang, HubeiHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ausper Biopharma Co., Ltd.
- Trial code
- NCT07635186
- Record updated
- 29 July 2026
- Original description
This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B.
This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.
Inclusion: Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol; Aged 18-65 years (including boundary values); Body mass index between the range of 18-32 kg/m2 (inclusive boundary values); HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue; HBsAg and HBV DNA values met protocol requirements at screening; ALT < 3xULN at screening; Use highly effective contraception as required.
Exclusion: Participants with other clinically significant liver diseases, previous/current manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status; Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization; Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial; Current use or use of any immunosuppressive medication (e.g. prednisone) within 3 months prior to screening, except for short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators within 3 months prior to screening;Those who have used cytotoxic drugs within 6 months prior to screening;History of vaccination within 1 month prior to screening or a live vaccination plan during the trial; Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B; Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection; Hepatitis C virus (HCV) infection or < 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive); Participants with confirmed or suspected liver cancer who have a history of malignancy within the past 5 years or are undergoing assessment for a possible malignancy; Allergic to AHB-137 ingredients, or history of drug allergy or other allergies; Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial; Laboratory test results do not meet the criteria; Prior/current autoimmune disease, history of vasculitis, or presence of signs, symptoms, or laboratory tests of underlying vasculitis; Fridericia ' s formula corrected QT interval (QTcF) ≥ 450 msec for male participants and ≥ 470 msec for female participants at screening; Significant fibrosis or cirrhosis, or liver stiffness value (LSM) > 9.0 kPa at screening; Participants are participating in another clinical trial or failing to wash out as required; Participants that require regular long-term anticoagulants; Abnormal thyroid function.