Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.

Más betegség

• A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, autoimmune or other immune-mediated disease.
• HIV or Hep C positive
• Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.
• Have or had liver cancer (hepatocellular carcinoma)
• Have a history or current autoimmune disease or has been on immunosuppressive medications within 6 months of the start of the study
• Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.

Egyéb

• Clinically significant lab abnormalities
• Have extensive fibrosis or cirrhosis of the liver
• Females who breastfeeding, pregnant or who wish to become pregnant during the study

• Male between ages 18-50 years
• Willing and able to provide informed consent
  • Willing to follow protocol-specified contraception requirement
• 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