A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAusper Biopharma Co., Ltd.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • AHB-137
  • Placebo

Treatment groups

320 Participants
are divided into 2 treatment groups

Sponsors and collaborators