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

Primary Purpose

Chronic Hepatitis B

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

ABI-H3733

Placebo

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring cHBV, HBV, Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Diagnostic Consultative Center Aleksandrovska
Acibadem City Clinic Tokuda Hospital
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
University of Hong Kong
ICS Arensia Exploratory Medicine Republican Clinical Hospital "Timofei Moșneaga"- Hospital
New Zealand Clinical Research
Institute of Infectious Diseases - Hospital ARENSIA Exploratory Medicine Research Clinic National Institute of Infectious Diseases "Matei Bals"
Clinical Trials and Research Centre, Singapore General Hospital
National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ABI-H3733

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax) of ABI-H3733 in subjects with cHBV

Minimum Plasma Concentration (Cmin) of ABI-H3733 in subjects with cHBV

Area Under Plasma Concentration-Time Curve (AUC) of ABI-H3733 in subjects with cHBV

Time to Maximum Plasma Concentration (Tmax) of ABI-H3733 in subjects with cHBV

Elimination half-life (t1/2) of ABI-H3733 in subjects with cHBV

To evaluate the effect of food on Cmax of ABI-H3733 in subjects with cHBV

To evaluate the effect of food on AUC of ABI-H3733 in subjects with cHBV

To evaluate the effect of food on the proportion of subjects with AEs, premature discontinuation due to AEs and abnormal laboratory results

To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV by Quantitative PCR

Full Information

NCT ID

NCT05414981

First Posted

June 2, 2022

Last Updated

June 28, 2023

Sponsor

Assembly Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT05414981

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

August 7, 2022 (Actual)

Primary Completion Date

April 24, 2023 (Actual)

Study Completion Date

April 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assembly Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B

Keywords

cHBV, HBV, Hepatitis B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABI-H3733

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ABI-H3733

Intervention Description

25 mg or 100 mg tablets for oral administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

25 mg or 100 mg tablets for oral administration

Primary Outcome Measure Information:

Title

Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results

Time Frame

Through end of study, up to 56 days

Secondary Outcome Measure Information:

Title

Maximum Plasma Concentration (Cmax) of ABI-H3733 in subjects with cHBV

Time Frame