Study of AHB-171 in Chronic Hepatitis B Participants (EXTEND-101)

AusperBio Therapeutics

Status and phase: Begins enrollment this month; Phase 1

Conditions: Hepatitis B, Chronic

Treatments: Drug: Nucleos(t)ide Analogue (NA); Drug: Placebo matching [Investigational Product]; Drug: AHB-171

Study type: Interventional

Funder types: Industry

Identifiers

NCT07617194

AB-17-8001

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• For Parts A and B, on stable approved NA monotherapy for at least 6 months prior to randomization.
• For Part C and D only, not on any NA monotherapy for at least 6 months prior to randomization.
• Screening electrocardiogram (ECG) without clinically significant abnormalities
• Females of childbearing potential must not be breastfeeding, must have a negative serum pregnancy test at Screening, and a negative urine/serum pregnancy test before dosing (unless permanently sterile or >2 years postmenopausal).
• Males and females of childbearing potential must agree to use protocol specified reliable contraception throughout the study.
• Screening HBV DNA, HBsAg and ALT must meet prespecified requirements.

Exclusion criteria

• 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.
• HBV-related extrahepatic diseases (e.g. kidney or vascular conditions).
• Severe infection (other than chronic HBV infection) within 1 month before randomization requiring intravenous treatment.
• Active infections: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV) or syphilis (exceptions if RNA negative).
• Abnormal lab results (e.g. low albumin, reduced kidney function, abnormal INR, low platelets, high bilirubin, abnormal blood counts, significant proteinuria).
• History or signs of vasculitis or related autoimmune diseases.
• Malignancy within 5 years (except non-melanoma skin cancer).
• Allergy to study drug components.
• Recent major surgery/trauma (within 3 months) or planned surgery during study.
• Alcohol or substance abuse affecting compliance.
• Pregnancy, breastfeeding, or unwillingness to follow reproductive restrictions.
• Participation in another clinical trial or recent investigational product use.
• Prior treatment with any antisense oligonucleotide or small interfering RNA therapies.
• Recent or ongoing use of immunosuppressive/biologic therapies, certain vaccines, bulevirtide, or unapproved herbal remedies.
• Need for long-term anticoagulants/antiplatelet drugs (unless safely stopped).
• Any other condition making the participant unsuitable (per investigator).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 4 patient groups

AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD])

Experimental group

Treatment:

Drug: AHB-171

Drug: Placebo matching [Investigational Product]

Drug: Nucleos(t)ide Analogue (NA)

AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])

Experimental group

Treatment:

Drug: AHB-171

Drug: Placebo matching [Investigational Product]

Drug: Nucleos(t)ide Analogue (NA)

AHB-171 and placebo in CHB (Part C: finite MD)

Experimental group

Treatment:

Drug: AHB-171

Drug: Placebo matching [Investigational Product]

AHB-171 and placebo in CHB (Part D: finite MD)

Experimental group

Treatment:

Drug: AHB-171

Drug: Placebo matching [Investigational Product]