Chronic Hepatitis B
Conditions
Keywords
cHBV, HBV, Hepatitis B
Brief summary
This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-4334 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-4334 or placebo.
Interventions
DRUGABI-4334
10 mg or 50 mg tablets for oral administration
DRUGPlacebo
10 mg or 50 mg tablets for oral administration
Sponsors
Assembly Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Triple (Participant, Care Provider, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses | Through end of study, up to 56 days | Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV | Through treatment period, up to 28 days | Noncompartmental plasma PK parameters |
| Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334 | Through treatment period, up to 28 days | Mean change in log10 HBV DNA between Baseline and Day 28 |
| Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV | Through treatment period, up to 28 days | — |
| Changes in HBV pregenomic ribonucleic acid (pgRNA) and additional markers of antiviral activity in subjects with cHBV | Through treatment period, up to 28 days | To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV |
Countries
Moldova, New Zealand
Outcome results
None listed