Hepatitis b drug trial halted early after safety check
NCT ID NCT02797522
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested an experimental drug called ARC-521 in healthy volunteers and people with chronic hepatitis B. The main goal was to check safety and how the body processes the drug. The study was terminated early, so results are limited.
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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
-
47 people
The number who actually took part.
- Started
-
Jun 2016
- Finished
-
Nov 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 65 years
- Sex
-
Anyone
- Healthy volunteers
-
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 to 55 years of age inclusive (NHVs) or 18-65 years of age inclusive (CHBs), at the time of informed consent * Able to provide written informed consent prior to the performance of any study specific procedures * Body mass index (BMI) between 19.0 and 35.0 kg/m2, inclusive * A 12-lead ECG at Screening and pre-dose assessment that, in the opinion of the investigator, has no abnormalities that compromise participant's safety in this study * Must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive (both male and female partners) * Have suitable venous access for blood sampling * No abnormal finding of clinical relevance at the Screening evaluation (NHVs only) * Have a diagnosis of HbeAg-negative chronic HBV infection (CHB patients only) * Treatment-naive or currently on entecavir/tenofovir for 6 months or longer Exclusion Criteria: * Pregnant or lactating * Acute signs of hepatitis/other infection at Screening or at baseline * Use within last 14 days or anticipated requirement for anticoagulants, systemic corticosteroids, immunomodulators, or immunosuppressants * Use of prescription medication within 14 days prior to study treatment that in the opinion of the PI or the Sponsor would interfere with study conduct. * Known diagnosis of non-alcoholic steatohepatitis \[NHVs only\] or familial hypercholesterolemia * Taking interferon alpha (INFalpha) within 6 months of screening \[CHBs only\] * History of poorly controlled autoimmune disease or history of autoimmune hepatitis * Human immunodeficiency virus (HIV) infection * Seropositive for HBV (NHVs only) or hepatitis C virus (HCV), and/or history of delta virus hepatitis * Hypertension defined as blood pressure \> 170/100 mmHg at screening \[NHVs only\] * A 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 within the last 5 years except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer * History of major surgery within 3 months of Screening * Regular use of alcohol within one month prior to the Screening visit (more than fourteen units of alcohol per week) * Evidence of severe systemic acute inflammation, sepsis, or hemolysis \[NHVs only\] * Use within 3 months of illicit drugs (cocaine, phencyclidine \[PCP\], 3,4-methylenedioxymethamphetamine \[MDMA\], others) or positive test for drugs of abuse at screening. * History of allergy to bee venom or history of severe hypersensitivity reaction, such as anaphylaxis * Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study * Clinically significant history of any alcoholic liver disease, cirrhosis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency, liver or kidney disease * Clinically significant history/presence of poorly controlled or decompensated neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, metabolic, or other uncontrolled systemic disease * Blood donation (500 mL) within 7 days prior to study treatment administration \[NHVs only\] * History of fever (\>38.0ºC/100.4ºF) within 2 weeks of Screening \[NHVs only\] * Any concomitant medical or psychiatric condition or social situation that impacts compliance or involves additional safety risk * History of coagulopathy (including deep vein thrombosis and pulmonary embolism) or stroke within 6 months of baseline, and/or concurrent anticoagulant medication(s) * Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction
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Conditions
The condition(s) this trial relates to.
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
Grafton, Auckland, 1011, New Zealand
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Other studies related to the condition(s) this trial covers.
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