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Healthy volunteers test new hepatitis b Drug's safety

NCT ID NCT02535416

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Research Site 1

    Herston, Queensland, 4029, Australia

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