Hepatitis BPhase 1NCT06422767
Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers
A Phase 1 study testing Bepirovirsen in people with Hepatitis B, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will evaluate the effect of a single dose of bepirovirsen on the QT interval corrected by Fridericia's formula (QTcF) as compared to placebo. The data generated will be used to model the relationship between bepirovirsen concentration and QTcF. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Bepirovirsen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2024to 28 Apr 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers
This study will evaluate the effect of a single dose of bepirovirsen on the QT interval corrected by Fridericia's formula (QTcF) as compared to placebo. The data generated will be used to model the relationship between bepirovirsen concentration and QTcF.
- Conditions
- Hepatitis B
- Being tested
- Bepirovirsen, Placebo
- Keywords
- Bepirovirsen, Cardiac Conduction, Electrocardiogram, QT interval corrected by Fridericia's formula, Hepatitis B virus
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BepirovirsenDrug
Bepirovirsen was administered.
PlaceboDrug
Placebo was administered.
| Study group | Role | What they receive |
|---|---|---|
| Bepirovirsen: Four-Dose SC Injection | Active comparator | Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1. Receives: Drug: Bepirovirsen |
| Placebo: Four SC Injections | Placebo comparator | Participants received four matching placebo SC injections on Day 1. Receives: Drug: Placebo |
| Bepirovirsen: Three-Dose SC Injection | Active comparator | Participant received three SC injections of Bepirovirsen dose level 1 on Day 1. Receives: Drug: Bepirovirsen |
| Placebo: Three SC Injections | Placebo comparator | Participants received three matching placebo SC injections on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected Change From Baseline (CFB) in QT Interval Corrected by Fridericia's Formula (QTcF) Following Administration of Bepirovirsen Supratherapeutic Single Dose
Continuous 12-lead electrocardiogram (ECG) was captured by Holter monitor. QTcF was measured from 10 digital ECGs extracted from the continuous tracing after 10 minutes of rest in supine position. Baseline was defined as pre-dose value on Day 1. Change from Baseline (CFB) was calculated by subtracting post-dose visit value from Baseline value. Geometric mean and 90 percent (%) Confidence Interval (CI) of predicted CFB QTcF adjusted for placebo at Cmax following supratherapeutic single doses of Bepirovirsen was presented using concentration QTc (C-QTc) analysis using exposure-response modelling. This approach utilized pre-specified linear mixed effects model where CFB QTcF was dependent variable. Fixed-effect parameters included intercept, slope, influence of Baseline on intercept, treatment and nominal time from first dose. Participant was included as additive random effect on both intercept and slope terms.
Measured: Baseline (Pre-dose on Day 1) and Day 4
Secondary outcomes (10)
Change From Baseline in RR Interval in ECG at Indicated Timepoints
Twelve-lead ECGs were extracted from continuous Holter monitor tracings and RR interval was measured. RR interval is the time duration between the peak of one R wave and the peak of the very next R wave on the ECG. RR interval represents the time between two consecutive heartbeats. ECGs were extracted after a 10 minute supine rest period. Baseline was defined as pre-dose value on Day 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Measured: Baseline (Pre-dose on Day 1) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints
Continuous 12-lead ECG was captured by Holter monitor. QTcF, PR interval and QRS duration were measured from 10 digital ECGs extracted from the continuous tracing after 10 minutes of rest in supine position. Baseline was defined as pre-dose value on Day 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Measured: Baseline (Pre-dose on Day 1) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Number of Participants With Outlier Results for Heart Rate (HR)
Continuous 12-lead ECG was captured by Holter monitor. HR was measured from 10 digital ECGs extracted from the continuous tracing after 10 minutes of rest in supine position. Participants with HR less than (<) 50 beats per minute (bpm) with a decrease of HR greater than (>) 25% and HR >100 bpm with an increase of HR >25% were considered as outlier.
Measured: Up to Day 4
Number of Participants With Outlier Results for Total QTcF Interval, PR Interval and QRS Duration
Twelve-lead ECG were obtained to measure QTcF interval, PR interval and QRS duration. 12-lead ECG were recorded in a participant using an ECG machine after 10 minutes rest in the supine position. Participants with outlier results were determined if the following criteria (which were assessed separately) were met: Participant who had treatment-emergent (TE) value of QTcF>450 and <=480 milliseconds (ms) when not present at Baseline (new onset); TE value of QTcF>480 and <=500 ms when not present at Baseline (new onset); TE value of QTcF>500 ms when not present at Baseline (new onset); increase of QTcF from Baseline of >30 and <=60 ms; increase of QTcF from baseline >60 ms; Increase in PR interval from Baseline >25% resulting in PR >200 ms; increase in QRS duration from Baseline >25% resulting in QRS >120 ms.
Measured: Up to Day 4
Number of Participants With Treatment Emergent Changes of T Wave Morphology and U-wave Presence
Twelve-lead ECG were obtained using an ECG machine. T-wave morphology was categorized as follows: Flat T wave: T amplitude <1 millimeter (mm) (either positive or negative) including flat isoelectric line. Notched T wave(+): Presence of notch(es) of at least 0.05 millivolt(mV) amplitude on ascending or descending arm of positive T wave. Biphasic: T wave that contains a second component with an opposite phase that is at least 0.1 mV deep (both positive/negative and negative/positive and polyphasic T waves included). T wave Inversion: T wave which normally points upward in most leads, is seen pointing downward (negative). Normal T wave(-): T amplitude that is negative, without biphasic T wave or notches. Notched T wave(-): Presence of notch(es) of at least 0.05 mV amplitude on descending or ascending arm of the negative T wave. U waves: Presence of abnormal U waves. Number of participants who had any treatment emergent changes of T wave morphology and U-wave presence have been presented.
Measured: Up to Day 4
Plasma Concentrations of Bepirovirsen
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of Bepirovirsen.
Measured: At 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Bepirovirsen
Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours Post-dose (AUC[0-24]) of Bepirovirsen
Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum Plasma Concentration (Cmax) of Bepirovirsen
Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Time to Reach Cmax (Tmax) of Bepirovirsen
Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start18 Jul 2024
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422767
- Sponsor's protocol ID
- 205873
- Status last verified
- Jun 2026
- First submitted
- 15 May 2024
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Publications
Delahaye JL, You S, Fu K, Van Buren S, Zhu C, Jordan W, Ray A, Freudenberg JM, Consalvo KM, Pagliaroli L, Joshi S, Dhawan P, Theodore D, Paff M, Walker J, Singh JM. Bepirovirsen induces innate immune proteins independent of HBV. Hepatol Int. 2026 Aug 4. doi: 10.1007/s12072-026-11134-z. Online ahead of print.
PubMed 42550463
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06422767
- Acronym / sponsor ID
- 205873
- Conditions
- Hepatitis B
- Keywords
- Bepirovirsen, Cardiac Conduction, Electrocardiogram, QT interval corrected by Fridericia's formula, Hepatitis B virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 21 May 2024 (actual)
- Results
- Posted 10 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of a single dose of bepirovirsen on the QT interval corrected by Fridericia's formula (QTcF) as compared to placebo. The data generated will be used to model the relationship between bepirovirsen concentration and QTcF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bepirovirsen: Four-Dose SC Injection | Active comparator | Drug: BepirovirsenParticipant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1. |
| Placebo: Four SC Injections | Placebo comparator | Drug: PlaceboParticipants received four matching placebo SC injections on Day 1. |
| Bepirovirsen: Three-Dose SC Injection | Active comparator | Drug: BepirovirsenParticipant received three SC injections of Bepirovirsen dose level 1 on Day 1. |
| Placebo: Three SC Injections | Placebo comparator | Drug: PlaceboParticipants received three matching placebo SC injections on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BepirovirsenBepirovirsen was administered. | Drug | Bepirovirsen: Four-Dose SC Injection, Bepirovirsen: Three-Dose SC Injection |
| PlaceboPlacebo was administered. | Drug | Placebo: Four SC Injections, Placebo: Three SC Injections |
Primary outcome
Placebo-corrected Change From Baseline (CFB) in QT Interval Corrected by Fridericia's Formula (QTcF) Following Administration of Bepirovirsen Supratherapeutic Single Dose
Time frame: Baseline (Pre-dose on Day 1) and Day 4
Continuous 12-lead electrocardiogram (ECG) was captured by Holter monitor. QTcF was measured from 10 digital ECGs extracted from the continuous tracing after 10 minutes of rest in supine position. Baseline was defined as pre-dose value on Day 1. Change from Baseline (CFB) was calculated by subtracting post-dose visit value from Baseline value. Geometric mean and 90 percent (%) Confidence Interval (CI) of predicted CFB QTcF adjusted for placebo at Cmax following supratherapeutic single doses of Bepirovirsen was presented using concentration QTc (C-QTc) analysis using exposure-response modelling. This approach utilized pre-specified linear mixed effects model where CFB QTcF was dependent variable. Fixed-effect parameters included intercept, slope, influence of Baseline on intercept, treatment and nominal time from first dose. Participant was included as additive random effect on both intercept and slope terms.
10 secondary outcomes
Change From Baseline in RR Interval in ECG at Indicated Timepoints
Time frame: Baseline (Pre-dose on Day 1) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints
Time frame: Baseline (Pre-dose on Day 1) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Number of Participants With Outlier Results for Heart Rate (HR)
Time frame: Up to Day 4
Number of Participants With Outlier Results for Total QTcF Interval, PR Interval and QRS Duration
Time frame: Up to Day 4
Number of Participants With Treatment Emergent Changes of T Wave Morphology and U-wave Presence
Time frame: Up to Day 4
Plasma Concentrations of Bepirovirsen
Time frame: At 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Bepirovirsen
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours Post-dose (AUC[0-24]) of Bepirovirsen
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum Plasma Concentration (Cmax) of Bepirovirsen
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Time to Reach Cmax (Tmax) of Bepirovirsen
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42550463Delahaye JL, You S, Fu K, Van Buren S, Zhu C, Jordan W, Ray A, Freudenberg JM, Consalvo KM, Pagliaroli L, Joshi S, Dhawan P, Theodore D, Paff M, Walker J, Singh JM. Bepirovirsen induces innate immune proteins independent of HBV. Hepatol Int. 2026 Aug 4. doi: 10.1007/s12072-026-11134-z. Online ahead of print.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bepirovirsen in people with Hepatitis B, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placebo-corrected Change From Baseline (CFB) in QT Interval Corrected by Fridericia's Formula (QTcF) Following Administration of Bepirovirsen Supratherapeutic Single Dose (time frame: Baseline (Pre-dose on Day 1) and Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06422767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.