study of arc-520 in participants with hepatitis b virus e antigen (hbeag) positive chronic hepatitis b virus

Conditions: Chronic Hepatitis B

Summary: participants with chronic hbv infection will receive multiple doses of arc-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.


Eligibility criteria:
inclusion criteria: * male or female, 18 to 75 years of age * written informed consent * body mass index (bmi) between 17.5 and 30.0 kg/m2 * no clinically significant abnormalities at screening/pre-dose 12-lead ecg assessment * no abnormal finding of clinical relevance * diagnosis of hbeag positive, immune active, chronic hbv infection * \> 2 months of continuous treatment with daily oral entecavir or tenofovir * must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive) exclusion criteria: * pregnant or lactating * acute signs of hepatitis/other infection within 4 weeks of screening * hepatic transaminases (alanine aminotransferase \[alt\] or aspartate aminotransferase \[ast\]) \> 3 times the upper limits of normal * liver elastography (i.e. fibroscan®) score \> 9 * antiviral therapy other than entecavir or tenofovir within 3 months of screening * prior treatment with interferon in the last 3 years * use of anticoagulants, corticosteroids, immunomodulators, or immunosuppressants within 6 months of screening * use within 7 days prior to screening of dietary and/or herbal supplements that can interfere with liver metabolism * use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days of study drug administration * use of prescription medication within 14 days prior to study drug administration * depot injection/implant of any drug except birth control within 3 months prior to study drug administration * known diagnosis of diabetes mellitus * history of autoimmune disease * human immunodeficiency virus (hiv) infection * sero-positive for hepatitis c virus (hcv), and/or a history of delta virus hepatitis * hypertension; blood pressure \> 150/100 mmhg * 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, except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, 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 (ie, more than 14 units of alcohol per week) * evidence of systemic acute inflammation, sepsis, or hemolysis * diagnosed with a significant psychiatric disorder * use of drugs of abuse * history of allergy to bee venom * positive reaction to the bee venom allergy immunoglobulin e (ige) test * use of investigational agents or devices within 30 days * clinically significant inherited or acquired gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease * presence of cholangitis, cholecystitis, cholestasis, or duct obstruction * clinically significant history or presence of uncontrolled systemic disease * donated or had a loss of whole blood of 50 milliliters (ml) to 499 ml within 30 days or more than 499 ml between 31 and 56 days prior to study treatment * history of fever within 2 weeks of screening * immunization/planned immunization with live attenuated vaccine except influenza vaccine * presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk * excessive exercise/physical activity within 7 days of screening/enrolment or during study * history of coagulopathy/stroke within past 6 months, and/or concurrent anticoagulant medication(s)

Keywords: hepatitis b virus chronic hepatitis b hbv