Study of AHB-171 in Chronic Hepatitis B Participants
ConditionHepatitis B, Chronic
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAusperBio Therapeutics Inc.
About this trial
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AHB-171 in participants with chronic hepatitis B (CHB). Study advancement to subsequent parts/cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol.
Eligibility criteria
Qualifiers
Male or female participants, aged 18-65 years old (inclusive)
Body Mass Index between 19 to 35 kg/m2 (inclusive)
Body weight > or = 45 kg.
Documented HBV infection for ≥6 months prior to randomization.
Disqualifiers
Significant medical conditions other than chronic HBV (e.g. recent heart issues, unstable cardiac disease, uncontrolled diabetes, bleeding disorders, prior organ transplant).
Other clinically significant liver diseases (e.g. hepatitis from other causes, autoimmune or alcoholic liver disease, prior liver failure).
History of suspected or confirmed cirrhosis (based on FibroScan® or biopsy).
Current, past, or suspected liver cancer, or elevated alpha-fetoprotein (AFP) ≥ 20 ng/mL.
Trial design
Treatments tested in this trial
- AHB-171
- Placebo matching [Investigational Product]
- Nucleos(t)ide Analogue (NA)
Treatment groups
144 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov