Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria for Healthy Subjects:

Male and Female between 18 and 55 years old
Female subjects must have a negative serum pregnancy test at screening
Subjects must be nonsmokers for at least 3 months prior to randomization
BMI 18.0 to 32.0 kg/m^2
Subjects must have a 12-lead ECG that meets protocol criteria

Inclusion Criteria for CHB Subjects:

Male and Female between 18 and 70 years old
Female subjects must have a negative serum pregnancy test at screening
BMI 18.0 to 35.0 kg/m^2
HBeAg-negative chronic hepatitis B or HBeAg-positive chronic hepatitis B and are currently receiving HBV NA treatment for ≥6 months prior to screening
Subjects must have a 12-lead ECG that meets protocol criteria

Exclusion Criteria for Healthy Subjects:

Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
Subjects with a history of clinically significant drug allergy
Subject with current or history of clinically significant (as determined by the Investigator) skin disease requiring intermittent or chronic treatment
Excessive use of alcohol defined as regular consumption of ≥14 units/week for women and ≥21 units/week for men
Unwilling to abstain from alcohol use for 48 hours prior to start of dosing through end of study follow up
Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)

Exclusion Criteria for CHB Subjects:

Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
Subjects with a history of clinically significant drug allergy
Subject with current or history of clinically significant (as determined by the Investigator) skin disease requiring intermittent or chronic treatment
Excessive use of alcohol defined as regular consumption of ≥14 units/week for women and ≥21 units/week for men
Subjects with Hepatitis A, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
Subject with any history or current evidence of hepatic decompensation such as: variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy, or active jaundice (within the last year)
Subjects must have absence of signs of hepatocellular carcinoma
Subjects with history or current liver cirrhosis
Subjects positive for anti-HBs anitbodies
Subjects with liver fibrosis that is classified as Metavir Score ≥F3