Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)

Exclusion Criteria

• •Pregnant or lactating
• •Acute signs of hepatitis/other severe infections within 4 weeks of screening
• •Use within the last 14 days or anticipated requirement for anticoagulants, systemic corticosteroids, immunomodulators, or immunosuppressants
• •Use of prescription medication within 14 days prior to treatment administration except: topical products without systemic absorption, statins (except rosuvastatin), hypertension medications, over-the-counter (OTC) and prescription pain medication or hormonal contraceptives
• •History of poorly controlled autoimmune disease or any history of autoimmune hepatitis
• •History of heterozygous or homozygous familial hypercholesterolemia.
• •Human immunodeficiency virus (HIV) infection
• •Is sero-positive for Hepatitis C Virus (HCV), or has a history of delta virus hepatitis (except for cohort in which delta virus infection is acceptable)
• •Has hypertension: blood pressure \> 170/100 mmHg; well-controlled blood pressure on hypertensive medication allowed
• •History of cardiac rhythm disturbances
• •Family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death
• •Symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease within 6 months prior to study entry
• •History of malignancy, except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer
• •Has had major surgery within 1 month of screening
• •Regular use of alcohol within 6 months prior to screening (ie, more than 14 units of alcohol per week)
• •Use of recreational drugs such as cocaine, phencyclidine (PCP), and methamphetamines, within 1 year prior to the screening
• •History of allergy to bee sting
• •Clinically significant history of any alcoholic liver disease, cirrhosis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency
• •Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction
• •Clinically significant history or presence of poorly controlled/uncontrolled systemic disease
• •Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk
• •History of coagulopathy/stroke within past 6 months, and/or concurrent anticoagulant medication(s)