Study of AHB-171 in Chronic Hepatitis B Participants

Phase 1Not Yet RecruitingNCT07617194

AusperBio Therapeutics Inc.144 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

144

Conditions

Hepatitis B, Chronic

Interventions

AHB-171DRUG

Injection

Placebo matching [Investigational Product]DRUG

Injection

Nucleos(t)ide Analogue (NA)DRUG

Oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Locations (2)

Queen Mary Hospital

Hong Kong, Hong Kong

New Zealand Clinical Research

Grafton, Auckland, New Zealand

Outcomes

Primary Outcomes

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

Time frame: Up to 72 weeks

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

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

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

Incidence of clinically significant changes in cardiac parameters [Safety and Tolerability]

12-lead electrocardiogram (ECG) abnormalities will be reported, with parameters evaluated including PR interval, QRS duration, QT/QTc interval.

Time frame: Up to 72 weeks

Incidence of laboratory abnormalities [Safety and Tolerability]

Time frame: Up to 72 weeks

The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: area under the curve from the time of dosing to the last measurable concentration (AUClast) of AHB-171

Time frame: Up to 72 weeks

Secondary Outcomes

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

Time frame: Up to 72 weeks

Central Contacts

Debbie Liao

CONTACT

(650) 650-2877 ausperbioclinicaltrials@ausperbio.com

Data from ClinicalTrials.gov

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