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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • AHB-171

    Drug

    Injection

  • Placebo matching [Investigational Product]

    Drug

    Injection

  • Nucleos(t)ide Analogue (NA)

    Drug

    Oral administration

Treatment groups

144 Participants
are divided into 4 treatment groups
Group A: AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD])Experimental treatment 3 interventions
Group B: AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])Experimental treatment 3 interventions
Group C: AHB-171 and placebo in CHB (Part C: finite MD)Experimental treatment 2 interventions
Group D: AHB-171 and placebo in CHB (Part D: finite MD)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events (AEs) [Safety and Tolerability]

Time frame
Up to 72 weeks
2

The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the maximum observed plasma concentration (Cmax) of AHB-171.

Time frame
Up to 72 weeks
3

The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the area under the concentration-time curve extrapolated to infinity (AUCinf ) of AHB-171

Time frame
Up to 72 weeks
4

Incidence of clinically significant changes in Vital Signs [Safety and Tolerability]

Vital signs include body temperature, pulse rate, respiratory rate, and blood pressure

Time frame
Up to 72 weeks

Secondary outcomes

1

Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study

Time frame
Up to 72 weeks
2

Absolute serum HBV (Hepatitis B virus) DNA and change from baseline across all evaluated timepoints in the study.

Time frame
Up to 72 weeks
3

Absolute serum HBeAb (Hepatitis B e Antibody) and change from baseline across all evaluated timepoints in the study.

Time frame
Up to 72 weeks
4

Proportion of participants achieving pre-specified HBsAg reduction levels or absolute thresholds across all evaluated timepoints in the study.

Time frame
Up to 72 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AusperBio Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: