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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Arrowhead Pharmaceuticals
• Treatments: Cetirizine; Diphenhydramine; Promethazine

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)