Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B

Key Inclusion Criteria:

• Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
• Adult males and non-pregnant, non-lactating females
• Documented evidence of chronic HBV infection with detectable hepatitis B surface antigen (HBsAg) levels
• On commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening
• HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to screening
• Screening Electrocardiogram (ECG) without clinically significant abnormalities

Key Exclusion Criteria:

• Extensive bridging fibrosis or cirrhosis
• Adults meeting any of the protocol defined exclusionary laboratory parameters at screening:

• Alanine aminotransferase (ALT) > 3x Upper Limit of Normal (ULN)
• International normalized ratio (INR) > ULN unless the adult is stable on an anticoagulant regimen
• Albumin < 3.5 g/dL
• Direct bilirubin > 1.5x ULN
• Platelet Count < 100,000/uL
• Estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault method)
• Co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus
• Prior history of hepatocellular carcinoma (HCC) or screening alpha-fetoprotein ≥ 50 ng/mL without imaging
• Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed.
• Chronic liver disease of a non-HBV etiology, except for non-alcoholic fatty liver disease
• Received solid organ or bone marrow transplant
• Received prolonged therapy with immunomodulators or biologics within 3 months of screening
• Use of another investigational agent within 90 days of screening, unless allowed by the Sponsor

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.