A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection

Exclusion Criteria

• •Pregnant or lactating
• •Acute signs of hepatitis/other infection within 4 weeks of screening
• •Antiviral therapy other than entecavir or tenofovir within 3 months of screening
• •Prior treatment with interferon in the last 3 years.
• •Use within the last 6 months or anticipated requirement for anticoagulants, 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, or hormonal contraceptives.
• •Depot injection or implant of any drug within 3 months prior to treatment administration, except injectable/implantable birth control.
• •Diagnosis of diabetes mellitus.
• •History of autoimmune disease especially autoimmune hepatitis.
• •Human immunodeficiency virus (HIV) infection.
• •Sero-positive for Hepatitis C Virus (HCV), and/or a history of delta virus hepatitis.
• •Hypertension defined as blood pressure \> 150/100 mmHg
• •History of cardiac rhythm disturbances
• •Family history or 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 a major surgery within 3 months of screening.
• •History of alcohol and/or drug abuse \< 12 months from screening.
• •Regular uses of alcohol within 6 months prior to screening (ie, more than 14 units of alcohol per week).
• •Evidence of severe systemic acute inflammation, sepsis, or hemolysis.
• •Diagnosed with a significant psychiatric disorder.
• •Use of recreational drugs, such as marijuana, within 3 months prior to screening
• •Use of drugs such as cocaine, phencyclidine (PCP), and methamphetamines, within 1 year prior to screening.
• •History of allergy to bee sting.
• •Use of investigational agents or devices within 30 days prior to planned study dosing or current participation in an investigational study.
• •Clinically significant history or presence of any gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease.
• •Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction.
• •Clinically significant history or presence of poorly controlled/uncontrolled systemic disease.
• •History of fever within 2 weeks of screening.
• •Immunized with a live attenuated vaccine within 7 days prior to dosing or planned vaccination (excluding flu vaccine by injection).
• •Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk.
• •Participated in excessive exercise/physical activity within 7 days of screening or planned during the trial.
• •History of coagulopathy/stroke within past 6 months, and/or concurrent anticoagulant medication(s).