AHB-137: AHB-137 will be administered subcutaneously.
Placebo: Placebo will be administered subcutaneously.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection.
* 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.
* 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).
* Significant fibrosis or cirrhosis, or liver stiffness value (LSM) \> 9.0 kPa at screening.
* 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.
* 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.
* Allergic to AHB-137 ingredients, or history of drug allergy or other allergies.
* Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial.
* Participants are participating in another clinical trial or failing to wash out as required.
* 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 require regular long-term anticoagulants.
* Abnormal thyroid function.
* Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B.
* Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial.
Primary outcome measure(s)
HBV DNA < lower limit of quantitation (LLOQ), 10 IU/mL, HBsAg < limit of detection (LOD), 0.05 IU/mL with or without hepatitis B virus surface antibody (HBsAb) 24 weeks after discontinuation of all chronic hepatitis B treatment. — Up to 48 weeks.
Highly sensitive HBsAg < 0.005 IU/mL and HBV DNA < LLOQ (10 IU/mL) at the end of treatment. — Up to 48 weeks.
Trial sites (34)
Facility
City
Region
Status
AusperBio Investigational Site
Beijing
Beijing Municipality
Recruiting
AusperBio Investigational Site
Chongqing
Chongqing Municipality
Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Chongqing Municipality
Recruiting
AusperBio Investigational Site
Xiamen
Fujian
Recruiting
AusperBio Investigational Site
Guangzhou
Guangdong
Recruiting
AusperBio Investigational Site
Guangzhou
Guangdong
Recruiting
AusperBio Investigational Site
Guangzhou
Guangdong
Recruiting
AusperBio Investigational Site
Jiangmen
Guangdong
Recruiting
AusperBio Investigational Site
Meizhou
Guangdong
Recruiting
AusperBio Investigational Site
Qingyuan
Guangdong
Recruiting
AusperBio Investigational Site
Shenzhen
Guangdong
Recruiting
AusperBio Investigational Site
Shenzhen
Guangdong
Recruiting
AusperBio Investigational Site
Liuzhou
Guangxi
Recruiting
AusperBio Investigational Site
Wuhan
Hubei
Recruiting
AusperBio Investigational Site
Wuhan
Hubei
Recruiting
AusperBio Investigational Site
Yichang
Hubei
Recruiting
AusperBio Investigational Site
Changsha
Hunan
Recruiting
AusperBio Investigational Site
Changsha
Hunan
Recruiting
AusperBio Investigational Site
Changsha
Hunan
Recruiting
AusperBio Investigational Site
Nanjing
Jiangsu
Recruiting
AusperBio Investigational Site
Nanchang
Jiangxi
Recruiting
AusperBio Investigational Site
Changchun
Jilin
Recruiting
AusperBio Investigational Site
Shenyang
Liaoning
Recruiting
AusperBio Investigational Site
Shanghai
Shanghai Municipality
Recruiting
AusperBio Investigational Site
Shanghai
Shanghai Municipality
Recruiting
AusperBio Investigational Site
Shanghai
Shanghai Municipality
Recruiting
AusperBio Investigational Site
Xi’an
Shanxi
Recruiting
AusperBio Investigational Site
Xi’an
Shanxi
Recruiting
AusperBio Investigational Site
Chengdu
Sichuan
Recruiting
AusperBio Investigational Site
Chengdu
Sichuan
Recruiting
AusperBio Investigational Site
Chengdu
Sichuan
Recruiting
AusperBio Investigational Site
Kunming
Yunan
Recruiting
AusperBio Investigational Site
Hangzhou
Zhejiang
Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
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.
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