A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

Phase 1 Completed 86 enrolled Assembly Biosciences

RandomizedParallel-groupSingle-blindTreatment

Summary

This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.

Timeline

Start: 2016-11
Primary completion: 2018-03-31
Completion: 2018-06-12

Publications

Yuen MF, Agarwal K, Gane EJ, Schwabe C, Ahn SH, Kim DJ, Lim YS, Cheng W, Sievert W, Visvanathan K, Ruby E, Liaw S, Yan R, Huang Q, Colonno R, Lopatin U. Safety, pharmacokinetics, and antiviral effects of ABI-H0731, a hepatitis B virus core inhibitor: a randomised, placebo-controlled phase 1 trial. Lancet Gastroenterol Hepatol. 2020 Feb;5(2):152-166. doi: 10.1016/S2468-1253(19)30346-2. Epub 2019 Nov 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vebicorvir	Small molecule	100 mg	Oral
Subject	Vebicorvir	Small molecule	200 mg	Oral
Subject	Vebicorvir	Small molecule	300 mg	Oral
Subject	Vebicorvir	Small molecule	400 mg	Oral
Subject	Vebicorvir	Small molecule	600 mg	Oral
Subject	Vebicorvir	Small molecule	800 mg	Oral
Subject	Vebicorvir	Small molecule	1000 mg	Oral
Background	Entecavir	Small molecule	—	—
Background	Peginterferon alfa-2a	Protein / enzyme biologic	—	—
Background	Tenofovir disoproxil fumarate	Small molecule	—	—

A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

Summary

Timeline

Publications

Drugs

Indications