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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: ABI-H3733; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda Hospital
  • Sofia, Bulgaria, 1606
    • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
  • Sofia City
    • Sofia, Sofia City, Bulgaria, 1431
      • Diagnostic Consultative Center Aleksandrovska
• Hong Kong
  • Hong Kong, Hong Kong
    • University of Hong Kong
• Moldova, Republic of
  • Chisinau, Moldova, Republic of, MD-2025
    • ICS Arensia Exploratory Medicine Republican Clinical Hospital "Timofei Moșneaga"- Hospital
• New Zealand
  • Auckland
    • Grafton, Auckland, New Zealand, 1051
      • New Zealand Clinical Research
• Romania
  • Bucharest, Romania, 021105
    • Institute of Infectious Diseases - Hospital ARENSIA Exploratory Medicine Research Clinic National Institute of Infectious Diseases "Matei Bals"
• Singapore
  • Singapore, Singapore
    • National University Hospital
  • Singapore, Singapore, 168753
    • Clinical Trials and Research Centre, Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Assembly Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2022
• Primary Completion (Actual): April 24, 2023
• Study Completion (Actual): April 24, 2023

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Hepatitis B; cHBV; HBV
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis A; Virus Diseases; Hepatitis B, Chronic; Hepatitis, Chronic; Herpesviridae Infections
• Other Study ID Numbers: ABI-H3733-102; 2022-000318-32 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No