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
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
- BeijingBeijing, ChinaTaking people
- ChangchunChangchun, ChinaTaking people
- ChangshaChangsha, ChinaTaking people
- ChengduChengdu, ChinaTaking people
- ChongqingChongqing, ChinaTaking people
- The Second Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
- GuangzhouGuangzhou, ChinaTaking people
- HangzhouHangzhou, ChinaTaking people
- The First Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaTaking people
- JiangmenJiangmen, ChinaTaking people
- KunmingKunming, ChinaTaking people
- LiuzhouLiuzhou, ChinaTaking people
- MeizhouMeizhou, ChinaTaking people
- NanchangNanchang, ChinaTaking people
- NanjingNanjing, ChinaTaking people
- QingyuanQingyuan, ChinaTaking people
- ShanghaiShanghai, ChinaTaking people
- ShenyangShenyang, ChinaTaking people
- ShenzhenShenzhen, ChinaTaking people
- WuhanWuhan, ChinaTaking people
- Xi’anXi’an, ChinaTaking people
- XiamenXiamen, ChinaTaking people
- YichangYichang, ChinaTaking 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?
Trial 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.