HepB mAb19 in Individuals With Chronic Hepatitis B Infection

Exclusion Criteria

• •\- Clinical symptoms, imaging studies or liver histology suggestive of advanced fibrosis (exclude fibrosis grade 3 and 4 by FibroScan (Fibroscan®\< 9 kpa) within 12 months from entry or done at the pre-infusion visit.
• •Note: If FibroScan results from within 12 months are not available, imaging will be performed at the pre-infusion visit.
• •Presence of a LI-RADS4 or 5 liver lesion on imaging within 12 months from entry or done at pre-infusion visit, if prior results not available.
• •Alpha fetoprotein \> 20 ng/ml Note: AFP above normal but \< 20 is acceptable for entry if earlier AFP levels (older than 6 months) are within normal range and imaging is negative in last 3 months).
• •HIV-1, HCV or hepatitis delta virus infection within 12 months from entry or done at screen, if prior results not available.
• •History of hematopoietic stem cell transplant or solid organ transplant;
• •Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, monoclonal antibody or vaccine, or multiple drug allergies (non-active hay fever is acceptable);
• •History of cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death);
• •History or presence of clinically significant ECG abnormalities based on the average of the triplicate ECG recordings (e.g., QT corrected for heart rate using the Fridericia's correction factor \[QTcF\] \> 450 ms for males and QTcF \> 470 ms for females);
• •History of systemic corticosteroids, immunosuppressive anti-cancer, systemic interferons or interleukins within the last 6 months;
• •History of chronic liver disease from another cause, immune complex disease, or autoimmune diseases that in the opinion of the investigator would preclude participation.
• •Any significant acute infection (e.g. influenza, COVID-19) or any other clinically significant illness within 2 weeks prior to Day 0.
• •Laboratory abnormalities in the parameters listed below:
• •Absolute neutrophil count \< 1,000 /mm3
• •Hemoglobin \< 10 gm/dL
• •Platelet count \< 150,000 /mm3
• •ALT \> 2.0 x ULN
• •AST \> 2.0 x ULN
• •Total bilirubin \> 1.5 ULN (except individuals with known Gilbert's)
• •Albumin \< 3.5 gm/dL
• •Calculated creatinine clearance \< 70 mL/min (using the Cockcroft Gault formula).
• •INR \>/= 1.2
• •Pregnancy or lactation;
• •Any vaccination within 14 days prior to IP administration;
• •Receipt of anti-HBV mAb therapy of any kind in the past (including HBIG);
• •Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.