A Study to Evaluate AB 452 in Subjects with Chronic HBV Infection

• Research type

  Research Study

• Full title

  A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AB-452 Following Oral Administration in Healthy Subjects and Subjects with Chronic Hepatitis B

• IRAS ID

  253864

• Contact name

  Kosh Agarwal

• Contact email

  kosh.agarwal@nhs.net

• Sponsor organisation

  Arbutus Biopharma Corporation

• Eudract number

  2018-001800-13

• Duration of Study in the UK

  0 years, 10 months, 9 days

• Research summary

  A two-part study to evaluate the safety and tolerability of AB452 following oral administration of single and multiple doses to healthy volunteers (Part 1) and participants with chronic hepatitis B virus(Part 2).

  Part 2 - involving participants with chronic hepatitis B (CHB) virus only.
  
  The UK will only participate in Part 2 of the study which will commence once data from Part 1 have been evaluated and the Safety Review Committee considers it is safe to proceed.

  Approximately 48 participants with CHB will be enrolled in Part 2 in one of four cohorts D, E, F (for participants who are already taking treatment for CHB) or G (for participants who have never taken treatment for CHB). Each cohort will consist of 12 participants who will be randomised to receive either AB-452 or matching placebo once or twice every day for a maximum of 28 days.

  The study duration for Part 2 including screening, treatment and post treatment follow up is not expected to exceed 12 weeks for each participant.

  The aim of Part 2 of the study is to find out:
  - How safe and how well tolerated AB-452 is and how the HBV and other signs of
  hepatitis B infection change when people who have CHB take it every
  day for 28 days.
  - How much of the dose and how quickly AB-452 is absorbed into the blood and then
  broken down or eliminated from the body.

  Safety and tolerability evaluations will include clinical laboratory tests, historical review of any symptoms, physical examination, vital signs, electrocardiograms, urinalysis and pregnancy tests.
  
  The effect of AB 452 will be assessed by comparing pre and post dose treatment HBV test results to determine the type and level of antibodies that are created by the immune system against the virus.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  18/LO/1684

• Date of REC Opinion

  18 Oct 2018

• REC opinion

  Favourable Opinion