A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection

This is an interventional treatment trial for Hepatitis B Read More

Inclusion Criteria:

• Male or female, 18 to 75 years of age.
• Written informed consent.
• No clinically significant abnormalities at screening/pre-dose 12-lead ECG assessment.
• No new abnormal finding of clinical relevance at the screening evaluation.
• Diagnosis of HBeAg positive, immune active, chronic HBV infection.
• > 2months of continuous treatment with daily, oral entecavir or tenofovir.
• Willingness to continue taking entecavir or tenofovir throughout the study.
• Must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive) (both male and female partners).

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 in the last 3 years.
• Use within the last 6 months or anticipated requirement for anticoagulants, corticosteroids, immunomodulators, or immunosuppressants.
• Use of prescription medication within 14 days prior to treatment administration except: topical products without systemic absorption, statins (except rosuvastatin), hypertension medications, or hormonal contraceptives.
• Depot injection or implant of any drug within 3 months prior to treatment administration, except injectable/implantable birth control.
• Diagnosis of diabetes mellitus.
• History of autoimmune disease especially autoimmune hepatitis.
• Human immunodeficiency virus (HIV) infection.
• Sero-positive for Hepatitis C Virus (HCV), and/or a history of delta virus hepatitis.
• Hypertension defined as blood pressure > 150/100 mmHg.
• History of cardiac rhythm disturbances.
• Family history or 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 except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer.
• Has had a major surgery within 3 months of screening.
• History of alcohol and/or drug abuse < 12 months from screening.
• Regular uses of alcohol within 6 months prior to screening (ie, more than 14 units of alcohol per week).
• Evidence of severe systemic acute inflammation, sepsis, or hemolysis.
• Diagnosed with a significant psychiatric disorder.
• Use of recreational drugs, such as marijuana, within 3 months prior to screening.
• Use of drugs such as cocaine, phencyclidine (PCP), and methamphetamines, within 1 year prior to screening.
• History of allergy to bee sting.
• Use of investigational agents or devices within 30 days prior to planned study dosing or current participation in an investigational study.
• Clinically significant history or presence of any gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease.
• Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction.
• Clinically significant history or presence of poorly controlled/uncontrolled systemic disease.
• History of fever within 2 weeks of screening.
• Immunized with a live attenuated vaccine within 7 days prior to dosing or planned vaccination (excluding flu vaccine by injection).
• Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk.
• Participated in excessive exercise/physical activity within 7 days of screening or planned during the trial.
• History of coagulopathy/stroke within past 6 months, and/or concurrent anticoagulant medication(s).