Around 16 chronic HBV patients will be enrolled in multi-center, randomized, double-blind, placebo-controlled, dose-escalation Phase IIa trial, which is being conducted at Queen Mary Hospital and Prince of Wales Hospital in Hong Kong.
In the trial patients will be divided into two dose groups and will be given either ARC-520 or placebo in combination with entecavir.
The Phase IIa trial is designed to assess the depth and duration of hepatitis B surface antigen (HBsAg) reduction after a single intravenous dose of ARC-520 in combination with entecavir in patients with chronic HBV infection.
According to the company, patient enrolment is expected to be completed in the second quarter of 2014, with top line results scheduled to be released in the third quarter of 2014.
In the trial, single doses of ARC-520 will be evaluated at up to two ascending doses of 1.0mg/kg and 2.0mg/kg.
The company said that at each of the two dose levels to be evaluated, a group of eight patients will be enrolled with six being dosed with ARC-520 and two being dosed with placebo.
The trial will be conducted in adult male and female patients aged 16 to 65 years, with immune active chronic HBV infection, HBV e antigen (HBeAg) negativity, and ongoing entecavir therapy.
Primary objective of the trial is to evaluate the depth and duration of HBsAg decline in response to a single dose of ARC-520 in combination with entecavir, while secondary objectives include evaluation of safety and tolerability and pharmacokinetic (PK) measures.