Phase 1b Study of ABI-H3733 in subjects with CHB virus infection

• Research type

  Research Study

• Full title

  A Randomized, Blinded, Placebo-Controlled, Dose-Ranging Phase 1b Study of the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects with Chronic Hepatitis B Virus Infection

• IRAS ID

  1005749

• Contact name

  Ashlynn Dundon

• Contact email

  adundon@assemblybio.com

• Sponsor organisation

  Assembly Biosciences, Inc.

• Eudract number

  2022-000318-32

• Clinicaltrials.gov Identifier

  NCT05414981

• Research summary

  The proposed study is a randomized, blinded, placebo-controlled, dose-ranging phase 1b study of the safety, pharmacokinetics, and antiviral activity of ABI-H3733 in subjects with chronic hepatitis B virus infection funded by Assembly Biosciences Inc.
  While standard-of-care (SOC) therapy with nucleos(t)ide reverse transcriptase inhibitors (NrtI) is able to achieve adequate viral suppression in most HBeAg negative patients and three quarters of HBeAg positive patients after 1 year, sustained virologic response (SVR) and loss of hepatitis B surface antigen (HBsAg) are rare (< 5%). New therapies, administered alone, in combination with NrtIs or agents of other mechanisms of action, are likely required to provide durable off-treatment virologic responses.

  The proposed study is a proof-of-concept study in subjects with cHBV evaluating the safety, pharmacokinetics (PK), and antiviral activity of ABI-H3733. The study drugs (ie, ABI-H3733 or placebo) will be administered orally, in a new tablet formulation to subjects with cHBV for 28 days, with the goal of selecting dose(s) for Phase 2 evaluation. Cohort 1 will evaluate 50 mg QD, Cohort 2 ≤ 150 mg, with up to 3 additional cohorts with dose levels/regimens to be determined based on emergent safety, PK, and antiviral activity data from previous cohorts.

  The study will include up to 50 participants (approx. 10 per cohort) and will involve participant assessments including vital signs, physical exams, liver staging, ECG and analysis of blood and urine samples.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  22/LO/0429

• Date of REC Opinion

  18 Aug 2022

• REC opinion

  Further Information Favourable Opinion