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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: ABI-H3733
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ABI-H3733<br> | Drug: ABI-H3733<br>* 25 mg or 100 mg tablets for oral administration<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 25 mg or 100 mg tablets for oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cHBV, HBV, Hepatitis B