The study is a phase 2a, single blind, randomized, placebo controlled, study evaluating the safety, anti-viral activity, and pharmacokinetics (PK) following multiple doses of intravenous ARB-001467
Approximately 24 subjects will be enrolled in three cohorts: two cohorts of HBeAg-negative subjects and one cohort of HBeAg-positive subjects and 12 HbeAg-negative subjects will be enrolled in cohort 4. All subjects will be non-cirrhotic, with chronic hepatitis B virus (HBV) infection, and will have been receiving nucleos(t)ide-analogue (NA) therapy with entecavir or tenofovir for at least 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
An IV infusion of ARB-001467
An IV infusion of placebo
Monash Health, Gastroenterology and Hepatology
Clayton, Victoria, Australia
The Alfred, Gastroenterology and Hepatology
Melbourne, Victoria, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia
Auckland Clinical Studies Ltd
Auckland, New Zealand
Frequency and severity of treatment-emergent SAEs, discontinuations due to AEs, and laboratory abnormalities, by cohort, through 28 days after the last infusion of study treatment.
To evaluate the safety and tolerability of multiple doses of ARB-001467 in HBeAg-negative and HBeAg-positive subjects with chronic Hepatitis B virus infection who are receiving nucleos(t)ide analogue therapy
Time frame: 28 days post last infusion
Evaluate ARB-001467 Maximum plasma concentration (Cmax) at multiple time points from baseline through Day 85; 28 days after the last infusion of study treatment (cohort 1-3) and Week 36 (Cohort 4).
To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection.
Time frame: Up to 36 Weeks
Evaluate ARB-001467 Time to maximum plasma concentration (Tmax) at multiple time points from baseline through Day 85; 28 days after the last infusion of study treatment (cohort 1-3) and Week 36 (Cohort 4).
To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection.
Time frame: Up to 36 Weeks
Evaluate ARB-001467 Area under the plasma concentration-time curve from the start of infusion to the last measurable concentration (AUC0-t) at multiple time points from baseline through Day 85 (cohort 1-3) and Week 36 (Cohort 4).
To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection.
Time frame: Up to 36 Weeks
Evaluate additional parameters for ARB-001467 from plasma concentration-time curve from start of infusion and extrapolated to infinity (AUC0-t), inf) partial, AUCs, T1/2, volume of distribution (VD) and clearance (CL) -baseline through Day 85 or Week 36.
To evaluate the pharmacokinetics of multiple doses of ARB-001467 in subjects with chronic HBV infection.
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Time frame: Up to 36 Weeks
Evaluate antiviral activity of ARB 001467 for up to 72 weeks after the first dose of study treatment.
The proportion of subjects in each dose level cohort with ≥0.5 log10 HBsAg decrease from baseline at EOS, and for these subjects, the changes from baseline (expressed as percentage and log10 change) in the following virologic markers will be assessed throughout the study: * Quantitative HBV surface antigen (HBsAg) * Quantitative HBV surface antibody (HBsAb) * Quantitative HBV DNA and HBV-RNA (viral load) For the HBeAg positive cohort only: \- Quantitative HBV e antigen (HBeAg)
Time frame: Up to 18 months