A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers

Inclusion Criteria

• Male or female, 18-55 years of age, inclusive
• Able to provide written informed consent
• BMI between 19.0 and 35.0 kg/m2, inclusive
• 12-lead ECG at Screening and pre-dose with no clinically significant abnormalities
• Highly effective, double barrier contraception (both male and female partners) during the study and for 3 months following the dose of ARC-520
• Willing and able to comply with all study assessments
• Suitable venous access for blood sampling
• Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and creatinine levels in the normal range
• No abnormal finding of clinical relevance

Exclusion Criteria

• Pregnant/lactating
• Acute signs of hepatitis/other infection within 4 weeks of Screening
• Concurrent use of anticoagulants, corticosteroids, immunomodulators, or immunosuppressants.
• Use of prescription medication within 14 days prior to study treatment
• Depot injection/implant other than birth control within 3 months of study treatment
• Known diagnosis of diabetes mellitus
• History of autoimmune disease especially autoimmune hepatitis.
• Human immunodeficiency virus (HIV) infection
• Sero-positive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Uncontrolled hypertension: blood pressure (BP) > 150/100 mmHg
• History of cardiac rhythm disturbances
• Family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death.
• Currently uses medications known to prolong the corrected QT interval (QTc).
• Symptomatic heart failure (per New York Heart Association guidelines)
• Unstable angina, myocardial infarction, severe cardiovascular disease, transient ischemic attack (TIA) or cerebrovascular accident (CVA) within past 6 months
• History of malignancy within last 5 years except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer
• Major surgery within 3 months of Screening
• History of alcohol and/or drug abuse < 12 months from Screening
• Regular use of alcohol within 6 months of Screening
• Evidence of systemic acute inflammation, sepsis or hemolysis.
• Clinically significant psychiatric disorder
• Use of recreational drugs within 3 months of Screening or drugs, such as cocaine, phencyclidine (PCP), and methamphetamines, within 1 year of Screening
• Positive urine drug screen
• History of allergy or hypersensitivity reaction to bee venom
• Positive reaction to the bee venom immunoglobulin E [IgE] test
• Use of investigational agents or devices within 30 days of study dosing or current participation in an investigational study.
• Clinically significant history/presence of any gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease
• Cholangitis, cholecystitis, cholestasis, or duct obstruction
• Clinically significant history/presence of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, metabolic or other uncontrolled systemic disease
• Blood donation or blood loss (500 mL) within 30 days prior to study treatment
• History of fever within 2 weeks of Screening.
• Excessive exercise/physical activity within 7 days of Screening or enrollment or planned during the study.
• History of coagulopathy, stroke within six (6) months of baseline, and/or concurrent anticoagulant medication(s)