This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-4334 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-4334 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
ARENSIA Exploratory Medicine Chisinau
Chisinau, Moldova
New Zealand Clinical Research
Auckland, New Zealand
To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
Time frame: Through end of study, up to 56 days
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
Noncompartmental plasma PK parameters
Time frame: Through treatment period, up to 28 days
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
Mean change in log10 HBV DNA between Baseline and Day 28
Time frame: Through treatment period, up to 28 days
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
Area Under Plasma Concentration-Time Curve (AUC) of ABI-4334 in subjects with cHBV
Time frame: Through treatment period, up to 28 days
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
Time to Maximum Plasma Concentration (Tmax) of ABI-4334 in subjects with cHBV
Time frame: Through treatment period, up to 28 days
Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV
Time frame: Through treatment period, up to 28 days
Changes in HBV pregenomic ribonucleic acid (pgRNA) and additional markers of antiviral activity in subjects with cHBV
To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Through treatment period, up to 28 days
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
Proportion of subjects with HBV DNA \< lower limit of quantification (LLOQ) and/or limit of detection (LOD)
Time frame: Through treatment period, up to 28 days
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
Mean time elapsed to subjects achieving HBV DNA \< LLOQ and/or LOD
Time frame: Through treatment period, up to 28 days