Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Selgantolimod (Formerly GS-9688) in Viremic Adult Participants With Chronic Hepatitis B (CHB) Who Are Not Currently on Treatment
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Placebo; Selgantolimod; TAF
Intervention description: Tablet(s) administered orally every 7 days for 24 doses in fasted state; Tablet(s) administered orally every 7 days for 24 doses in fasted state; Tablet(s) administered orally once daily with food
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the safety and tolerability of multiple
      oral doses of selgantolimod and to evaluate the antiviral activity of selgantolimod in adult
      participants with chronic hepatitis B (CHB) who are viremic and not currently being treated.
    

Eligibility criteria:

        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 male and non-pregnant, non-lactating females

          -  Documented evidence of chronic hepatitis B virus (HBV) infection with detectable
             hepatitis B surface antigen (HBsAg) levels at screening

          -  Screening HBV deoxyribonucleic acid (DNA) ≥ 2000 international units per milliliter
             (IU/mL).

          -  Screening electrocardiogram (ECG) without clinically significant abnormalities

        Key Exclusion Criteria:

          -  Extensive bridging fibrosis or cirrhosis

          -  Received a commercially available HBV OAV treatment(s) within the 3 months prior to
             screening.

          -  Received prolonged therapy with immunomodulators or biologics within 3 months of
             screening

          -  Individuals meeting any of the following laboratory parameters at screening:

               -  Alanine aminotransferase > 5 * upper limit of normal (ULN)

               -  International normalized ratio > ULN unless the individual is stable on an
                  anticoagulant regimen

               -  Albumin < 3.5 g/dL

               -  Direct bilirubin >1.5x ULN

               -  Platelet Count < 100,000/µL

               -  Estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault method)

          -  Co-infection with human immunodeficiency virus (HIV), hepatitis C virus or hepatitis D
             virus

          -  Prior history of hepatocellular carcinoma 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.

          -  Use of another investigational agent within 90 days of screening, unless allowed by
             the sponsor.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.