Study of AHB-171 in Chronic Hepatitis B Participants
ConditionHepatitis B, Chronic (CHB)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAusper Biopharma Co., Ltd.
About this trial
The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB)
Eligibility criteria
Qualifiers
Able to fully understand and sign the informed consent form (ICF).
Male or female participants, aged 18-65 years (inclusive).
Body mass index (BMI) meeting the predefined eligibility range.
Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening.
Disqualifiers
History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject unsuitable for study participation.
Prior history of solid organ or hematopoietic stem cell transplantation.
History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential immune activation risk.
History or presence of hepatic decompensation at screening.
Trial design
Treatments tested in this trial
- AHB-171 Injection
Treatment groups
138 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov