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-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.
Interventions
DRUGABI-H3733
25 mg or 100 mg tablets for oral administration
DRUGPlacebo
25 mg or 100 mg tablets for oral administration
Sponsors
Assembly Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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 5. Current or prior treatment for cHBV
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Maximum Plasma Concentration (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 |
| To evaluate the effect of food on Cmax of ABI-H3733 in subjects with cHBV | Through treatment period, up to 28 days |
Countries
Bulgaria, Hong Kong, Moldova, New Zealand, Romania, Singapore
Outcome results
None listed