Study of ARC-520 in Patient With Chronic Hepatitis B Virus

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 or a toll receptor agonist in last 12 months
• •Use of anticoagulants, corticosteroids, immunomodulators, or immunosuppressants
• •Use of dietary and/or herbal supplements that can interfere with liver metabolism
• •Use of any drugs known to induce or inhibit hepatic drug metabolism
• •Use of prescription medication or over-the-counter products
• •Depot injection/implant of any drug except birth control.
• •Known diagnosis of diabetes mellitus.
• •History of autoimmune disease
• •Human immunodeficiency virus (HIV) infection
• •Sero-positive for HCV, and/or history of delta virus hepatitis
• •Hypertension: blood pressure \> 150/100 mmHg
• •History of cardiac rhythm disturbances
• •Family history of congenital long QT syndrome/unexplained sudden cardiac death
• •Symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease
• •History of malignancy, except adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, in situ cervical cancer
• •Major surgery within 3 months of screening
• •History of alcohol and/or drug abuse \< 12 months from screening
• •Regularly uses alcohol within past 6 months (ie, more than 14 units of alcohol per week)
• •Evidence of acute inflammation, sepsis, or hemolysis
• •Diagnosed with a significant psychiatric disorder
• •Use of drugs of abuse
• •History of allergy to bee venom
• •Use of investigational agents/devices within 30 days
• •Current participation in an investigational study
• •Clinically significant gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease
• •History/presence of Gilbert's syndrome, conditions that interfere with absorption, distribution, metabolism, excretion of drugs
• •Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction
• •Clinically significant history/presence of uncontrolled systemic disease
• •Donated blood (500 mL) within 7 days prior to study treatment administration
• •History of fever within 2 weeks of screening
• •Immunization/planned immunization with live attenuated vaccine except influenza vaccine
• •Excessive exercise/physical activity within 7 days of screening/enrolment or during study
• •History of coagulopathy or stroke within past 6 months, and/or concurrent anticoagulants