Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B

• Research type

  Research Study

• Full title

  A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients with Chronic Hepatitis B

• IRAS ID

  223431

• Contact name

  Eric Ruby

• Contact email

  eruby@assemblybio.com

• Sponsor organisation

  Assembly Biosciences, Inc.

• Eudract number

  2017-000595-28

• Clinicaltrials.gov Identifier

  NCT03109730

• Duration of Study in the UK

  0 years, 10 months, 7 days

• Research summary

  Protocol ABI-H0731-101B is a Phase 1b/2a study looking at the effect of ABI-H0731 in hepatitis B infected patients. This study will evaluate the safety, tolerability, PK, and efficacy of ABI-H0731/placebo given for 28 days in HBV patients at up to 4 different doses. Assuming ABI-H0731 is safe and shows sufficient antiviral activity, a single dose of ABI-H0731/placebo will be selected to be given to Hep B patients for 28 days in combination therapy with standard of care nucleos(t)ides and pegylated interferon (PegIFN).

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  17/LO/0960

• Date of REC Opinion

  8 Sep 2017

• REC opinion

  Further Information Favourable Opinion