A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers
Condition: Healthy
Intervention: ARC-520; cetirizine; diphenhydramine
Intervention MeSH terms: Diphenhydramine; Promethazine; Cetirizine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Single doses of ARC-520 will be evaluated at varying infusion rates and by slow bolus push.
    

Eligibility criteria:

        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)