Healthy volunteers test new hepatitis b Drug's safety
NCT ID NCT02535416
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested the safety and how the body processes ARC-520, an experimental drug for hepatitis B, in 40 healthy adults. Participants received a single dose at different infusion speeds. The goal was to check for side effects and measure drug levels in the blood, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
40 people
The number who actually took part.
- Start date
-
Sep 2015
- Finished
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Aug 2016
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site 1
Herston, Queensland, 4029, Australia
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