Chronic Hepatitis B
Conditions
Keywords
CHB, HBV, hepatitis B, HBeAg positive
Brief summary
This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b, dose-ranging assessment of ABI-H2158 in non-cirrhotic, CHB patients.
Interventions
DRUGABI-H2158
5 mg or 25 mg tablets
DRUGPlacebo for ABI-H2158
Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets
Sponsors
Assembly Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers: 1. Male or female between 18 and 55 years old with a BMI of 18-34 kg/m2 with a minimum body weight of 45 kg 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 Chronic HBV patients: Key Inclusion Criteria: 1. Male or female ≥ 18 and ≤ 65 years of age. 2. In good general health except for chronic HBV infection, documented by: 1. Clinical history, physical exam and routine laboratory measurements without major or clinically significant findings 2. Serologic profile consistent with chronic HBV infection • HBeAg-positive at Screening with HBV viral load ≥ 2× 105 IU/mL 3. Liver evaluation demonstrating the absence of bridging fibrosis or cirrhosis Key
Exclusion criteria
1. History or evidence of decompensated liver disease at any time prior to Screening 2. History or presence of any other clinically significant current medical conditions requiring ongoing pharmacological treatment. 3. Previous treatment with any investigational HBV antiviral treatments within the last 6 months, or previous treatment at any time with an investigational HBV antiviral treatment of the same class (core protein targeted therapies). 4. Previous treatment with a commercially approved HBV therapy within the last 6 months
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 28 days |
Countries
Australia, China, Hong Kong, New Zealand, South Korea, United Kingdom, United States
Outcome results
None listed