A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)

Exclusion Criteria

• •Pregnant or lactating
• •Acute signs of hepatitis/other infection at Screening or at baseline
• •Use within last 14 days or anticipated requirement for anticoagulants, systemic corticosteroids, immunomodulators, or immunosuppressants
• •Use of prescription medication within 14 days prior to study treatment that in the opinion of the PI or the Sponsor would interfere with study conduct.
• •Known diagnosis of non-alcoholic steatohepatitis \[NHVs only\] or familial hypercholesterolemia
• •Taking interferon alpha (INFalpha) within 6 months of screening \[CHBs only\]
• •History of poorly controlled autoimmune disease or history of autoimmune hepatitis
• •Human immunodeficiency virus (HIV) infection
• •Seropositive for HBV (NHVs only) or hepatitis C virus (HCV), and/or history of delta virus hepatitis
• •Hypertension defined as blood pressure \> 170/100 mmHg at screening \[NHVs only\]
• •A 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 within the last 5 years except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer
• •History of major surgery within 3 months of Screening
• •Regular use of alcohol within one month prior to the Screening visit (more than fourteen units of alcohol per week)
• •Evidence of severe systemic acute inflammation, sepsis, or hemolysis \[NHVs only\]
• •Use within 3 months of illicit drugs (cocaine, phencyclidine \[PCP\], 3,4-methylenedioxymethamphetamine \[MDMA\], others) or positive test for drugs of abuse at screening.
• •History of allergy to bee venom or history of severe hypersensitivity reaction, such as anaphylaxis
• •Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
• •Clinically significant history of any alcoholic liver disease, cirrhosis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency, liver or kidney disease
• •Clinically significant history/presence of poorly controlled or decompensated neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, metabolic, or other uncontrolled systemic disease
• •Blood donation (500 mL) within 7 days prior to study treatment administration \[NHVs only\]
• •History of fever (\>38.0ºC/100.4ºF) within 2 weeks of Screening \[NHVs only\]
• •Any concomitant medical or psychiatric condition or social situation that impacts compliance or involves additional safety risk
• •History of coagulopathy (including deep vein thrombosis and pulmonary embolism) or stroke within 6 months of baseline, and/or concurrent anticoagulant medication(s)
• •Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction