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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
86
Unnamed facility
Auckland, New Zealand
Unnamed facility
Hamilton, New Zealand
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: Up to 57 days
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Used to treat adults with chronic hepatitis B virus
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Used to treat adults with chronic hepatitis B virus