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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05414981
• Other study ID #: ABI-H3733-102
• Secondary ID: 2022-000318-32
• Status: Completed
• Phase: Phase 1
• Start date: August 7, 2022
• Est. completion date: April 24, 2023

Study information

• Verified date: June 2023
• Source: Assembly Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Chronic hepatitis B infection, defined as HBV infection for =6 months documented

3. Treatment-naïve or off-antiviral therapy for =24 weeks prior to Screening

4. Lack of bridging fibrosis or cirrhosis

Exclusion Criteria:

1. 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)

2. History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation

3. Clinically significant diseases or conditions

4. History of hepatocellular carcinoma

5. Current or prior treatment for cHBV

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Herpesviridae Infections
• Virus Diseases

Intervention

Drug:
• ABI-H3733
25 mg or 100 mg tablets for oral administration
• Placebo
25 mg or 100 mg tablets for oral administration

Locations

Country	Name	City	State
Bulgaria	Acibadem City Clinic Tokuda Hospital	Sofia
Bulgaria	Diagnostic Consultative Center Aleksandrovska	Sofia	Sofia City
Bulgaria	Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia	Sofia
Hong Kong	University of Hong Kong	Hong Kong
Moldova, Republic of	ICS Arensia Exploratory Medicine Republican Clinical Hospital "Timofei Mo?neaga"- Hospital	Chisinau
New Zealand	New Zealand Clinical Research	Grafton	Auckland
Romania	Institute of Infectious Diseases - Hospital ARENSIA Exploratory Medicine Research Clinic National Institute of Infectious Diseases "Matei Bals"	Bucharest
Singapore	Clinical Trials and Research Centre, Singapore General Hospital	Singapore
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Assembly Biosciences

Countries where clinical trial is conducted

Bulgaria,  Hong Kong,  Moldova, Republic of,  New Zealand,  Romania,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum Plasma Concentration (Cmax) of ABI-H3733 in subjects with cHBV		Through treatment period, up to 28 days
Secondary	Minimum Plasma Concentration (Cmin) of ABI-H3733 in subjects with cHBV		Through treatment period, up to 28 days
Secondary	Area Under Plasma Concentration-Time Curve (AUC) of ABI-H3733 in subjects with cHBV		Through treatment period, up to 28 days
Secondary	Time to Maximum Plasma Concentration (Tmax) of ABI-H3733 in subjects with cHBV		Through treatment period, up to 28 days
Secondary	Elimination half-life (t1/2) of ABI-H3733 in subjects with cHBV		Through treatment period, up to 28 days
Secondary	To evaluate the effect of food on Cmax of ABI-H3733 in subjects with cHBV		Through treatment period, up to 28 days
Secondary	To evaluate the effect of food on AUC of ABI-H3733 in subjects with cHBV		Through treatment period, up to 28 days
Secondary	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
Secondary	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