Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arrowhead Pharmaceuticals
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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)
Clareo Health | Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus
