A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection

Sponsor

Assembly Biosciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05414981

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-H3733 or placebo.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Drug: ABI-H3733 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official 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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ABI-H3733	Drug: ABI-H3733 25 mg or 100 mg tablets for oral administration
Placebo Comparator: Placebo	Drug: Placebo 25 mg or 100 mg tablets for oral administration

Arm

Intervention/Treatment

Active Comparator: ABI-H3733

Drug: ABI-H3733

25 mg or 100 mg tablets for oral administration

Placebo Comparator: Placebo

Drug: Placebo

25 mg or 100 mg tablets for oral administration

Outcome Measures

Primary Outcome Measures

Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results [Through end of study, up to 56 days]

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax) of ABI-H3733 in subjects with cHBV [Through treatment period, up to 28 days]
Minimum Plasma Concentration (Cmin) of ABI-H3733 in subjects with cHBV [Through treatment period, up to 28 days]
Area Under Plasma Concentration-Time Curve (AUC) of ABI-H3733 in subjects with cHBV [Through treatment period, up to 28 days]
Time to Maximum Plasma Concentration (Tmax) of ABI-H3733 in subjects with cHBV [Through treatment period, up to 28 days]
Elimination half-life (t1/2) of ABI-H3733 in subjects with cHBV [Through treatment period, up to 28 days]
To evaluate the effect of food on Cmax of ABI-H3733 in subjects with cHBV [Through treatment period, up to 28 days]
To evaluate the effect of food on AUC of ABI-H3733 in subjects with cHBV [Through treatment period, up to 28 days]
To evaluate the effect of food on the proportion of subjects with AEs, premature discontinuation due to AEs and abnormal laboratory results [Through treatment period, up to 28 days]
To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV by Quantitative PCR [Through treatment period, up to 28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Body mass index (BMI) ≥ 18.0 and < 35.0 kg/m(2), where BMI = weight (kg)/(height [m])(2) with a minimum body weight of 45 kg.
Chronic hepatitis B infection, defined as HBV infection for ≥6 months documented
Treatment-naïve or off-antiviral therapy for ≥24 weeks prior to Screening
Lack of bridging fibrosis or cirrhosis

Exclusion Criteria:

Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV)
History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation
Clinically significant diseases or conditions
History of hepatocellular carcinoma
Current or prior treatment for cHBV

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diagnostic Consultative Center Aleksandrovska	Sofia	Sofia City	Bulgaria	1431
2	Acibadem City Clinic Tokuda Hospital	Sofia		Bulgaria	1407
3	Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia	Sofia		Bulgaria	1606
4	University of Hong Kong	Hong Kong		Hong Kong
5	ICS Arensia Exploratory Medicine Republican Clinical Hospital "Timofei Moșneaga"- Hospital	Chisinau		Moldova, Republic of	MD-2025
6	New Zealand Clinical Research	Grafton	Auckland	New Zealand	1051
7	Institute of Infectious Diseases - Hospital ARENSIA Exploratory Medicine Research Clinic National Institute of Infectious Diseases "Matei Bals"	Bucharest		Romania	021105
8	Clinical Trials and Research Centre, Singapore General Hospital	Singapore		Singapore	168753
9	National University Hospital	Singapore		Singapore
10	King's College Hospital	London		United Kingdom	SE5 9RS