Heart safety check for hepatitis b drug candidate
NCT ID NCT06422767
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This study investigates whether a single dose of bepirovirsen, a potential treatment for hepatitis B, affects the heart's electrical activity. Healthy adults aged 18 to 55 receive either the drug or a placebo, and their heart rhythms are monitored continuously by ECG. The goal is to see if bepirovirsen causes any changes in the QT interval, a measure linked to heart rhythm safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bepirovirsen
- What this could lead to
- If the drug shows no heart-rhythm effects, it may support further development of bepirovirsen as a treatment for hepatitis B.
- What could go wrong
- This is an early-phase safety study in healthy people, not patients. The drug could still cause heart issues or fail in later trials.
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
-
46 people
The number who actually took part.
- Started
-
Jul 2024
- Finished
-
Apr 2025
- 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 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: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, electrocardiogram (ECG) and vital signs. * Body weight greater than equal to (\>=) 50 Kilograms (kg) and Body mass index (BMI) within the range 19-32 Kilograms per square meter (kg/m\^2) (inclusive). * Study will enroll both male and female participants. o Female participants are eligible to participate if they are not pregnant or breastfeeding and are either not of childbearing potential or agree to using a highly effective method of contraception. * Capable of giving signed informed consent. Exclusion Criteria: * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. * History of vasculitis or presence of symptoms and signs of potential vasculitis * History of lymphoma, leukemia, or any malignancy except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for at least 3 years. * Participants with any other medical conditions which, in the judgement of the investigator and/or Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant. * Past, current or intended use of over-the-counter or prescription medication, including herbal medications within 7 days or 5 half-lives (whichever is longer) before dosing. * Current or recent use of creatine-containing supplements, or intended use up to 50 days post-dosing. * Prior treatment with any oligonucleotide or small interfering Ribonucleic acid (RNA) (siRNA) within 12 months before dosing. * Exposure to more than 4 new chemical entities within 12 months before the first dosing day * Current enrollment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within 5 half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or within the last 90 days (if half-life and duration of biological effect are unknown), before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research. * Current enrollment or past participation in this clinical study. * Positive pre-clinical drug/alcohol screen, including tetrahydrocannabinol. * Positive Human Immunodeficiency Virus antibody test. * History or regular use of tobacco or nicotine-containing products within 6 months prior to screening. * Regular alcohol consumption within 6 months prior to screening defined as an average weekly intake of \>14 units for males or females. * Regular use of known drugs of abuse, including tetrahydrocannabinol. * Sensitivity to heparin or history of heparin-induced thrombocytopenia. * History of sensitivity to bepirovirsen or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor contraindicates their participation. * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Positive test results for Hepatitis B surface antigen (HBsAg), hepatitis C antibody or hepatitis C RNA at screening or within 3 months prior to first dose of study intervention. * Known history of heart disease, including ischemic heart disease, cardiomyopathy, clinically significant cardiac arrhythmias, clinically significant valvular disease, or hypertensive heart disease.
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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
-
GSK Investigational Site
Austin, Texas, 78744 -1645, United States
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