Chronic Hepatitis B
Conditions
Brief summary
This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.
Interventions
DRUGABI-H0731
DRUGEntecavir
Used to treat adults with chronic hepatitis B virus
DRUGTenofovir disoproxil fumarate
Used to treat adults with chronic hepatitis B virus
DRUGPegasys
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
DRUGNucleos(t)ide
Used to treat adults with chronic hepatitis B virus
Sponsors
Assembly Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers: 1. Male or female between 18 and 65 years old with a BMI of 18-32kg/m2 2. Must be in good health and not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study CHB patients: 1. Male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2 and a minimum body weight of 45 kg 2. Must have chronic hepatitis B with no history of clinical decompensation 3. Seropositive for HIV, HCV, or HDV antibody at Screen 4. Previous treatment with any HBV antiviral treatments within the last 3 months 5. Other known cause of liver disease, including NASH
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0. | Up to 57 days |
Countries
New Zealand
Outcome results
None listed