Phase
Condition
Hepatitis B
Hepatitis
Liver Disorders
Treatment
Placebo
Nucleos(t)ide Analogue
AB-101
Clinical Study ID
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Part 1 and 2 (Healthy Volunteers)
Male between ages 18-50 years
Willing and able to provide informed consent
Willing to follow protocol-specified contraception requirement
Inclusion Criteria: Part 3 (CHB Subjects)
Male or female subjects between the ages of 18-60 years
Willing to provide informed consent
Chronic HBV infection for at least 6 months
Willing to follow protocol-specified contraception requirement
Exclusion
Exclusion Criteria: Part 1 and 2 (Healthy Volunteers)
Key Exclusion Criteria:
Clinically significant lab abnormalities
A history of clinically significant gastrointestinal, hematologic, renal, hepatic,bronchopulmonary, neurological, psychiatric, cardiovascular, autoimmune or otherimmune-mediated disease.
HIV or Hep C positive
Known chronic or severe infection or recent significant exposure to infections suchas tuberculosis or endemic mycosis, untreated latent infections like tuberculosis,or a positive or indeterminate QuantiFERON test.
Exclusion Criteria: Part 3 (CHB Subjects)
Have extensive fibrosis or cirrhosis of the liver
Have or had liver cancer (hepatocellular carcinoma)
Have a history or current autoimmune disease or has been on immunosuppressivemedications within 6 months of the start of the study
Females who breastfeeding, pregnant or who wish to become pregnant during the study
Known chronic or severe infection or recent significant exposure to infections suchas tuberculosis or endemic mycosis, untreated latent infections like tuberculosis,or a positive or indeterminate QuantiFERON test.
Study Design
Connect with a study center
Prince of Wales Hospital - Hong Kong
Hong Kong,
Hong KongActive - Recruiting
Queen Mary Hospital - PPDS
Hong Kong,
Hong KongActive - Recruiting
Clinial Republican Hospital "Timofei Mosneaga"
Chișinău,
Moldova, Republic ofActive - Recruiting
New Zealand Clinical Research Auckland
Grafton, Auckland 1010
New ZealandActive - Recruiting
New Zealand Clinical Research Auckland
Auckland,
New ZealandSite Not Available
Municipal Non-Profit Enterprise Kyiv City Clinical Hospital No12 Executive Body of Kyiv City Council
Kyiv,
UkraineActive - Recruiting
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