Hepatitis BPhase 1NCT06058390

A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants

A Phase 1 study testing Bepirovirsen in people with Hepatitis B, run by GlaxoSmithKline at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 2 sitesUnited States
Study dates: 4 Oct 2023to 3 May 2024
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

Healthy participants as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECGs) and vital signs.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and protocol.

Who cannot join

Past or current medical conditions which, in the judgement of the investigator and Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant.
Abnormal blood pressure as determined by the investigator.
Positive Hepatitis B virus (HBV), Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test results.
Participants with signs or symptoms suggestive of Coronavirus disease 2019 (COVID-19) within 14 days of inpatient admission, or with a positive test for active COVID-19 infection before study start.
Past, current or intended use of over the counter or prescription medication [including herbal medications]
Current or prior use of creatine-containing supplements and intended use up to 50 days post-dosing.

Show all 16Show fewer

Prior use of immunosuppressive drugs within 3 months before dosing or interferon within 12 months before dosing.
Prior treatment with any oligonucleotide or small interfering ribonucleoside (RNA) siRNA within 12 months before dosing.
Loss of blood or blood products in excess of 500 millilitre (mL) within any 3-month period during the study.
Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
Current enrolment 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 the first dosing day in the current study.
Current enrolment or past participation in this clinical study.
Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
Regular alcohol consumption of alcohol within 6 months prior to the study.
Regular use of known drugs of abuse, including Tetrahydrocannabinol (THC).
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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

GSK Investigational Site
Austin, Texas, 78744
GSK Investigational Site
Las Vegas, Nevada, 89113

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Open-Label, Parallel Group Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants

This is an open-label, randomized study to investigate subcutaneous (SC) bepirovirsen when delivered via SC injection from vial or Prefilled syringe fitted with a Safety syringe device (PFS SSD) in healthy adult participants. The aim of this study is to provide relative bioavailability data to support the transition from the vial presentation of bepirovirsen, to a ready-to-use liquid in a PFS SSD when both are given by a health care professional. The study will also assess self-administration using the PFS SDD, and the safety and tolerability of bepirovirsen.

Conditions: Hepatitis B
Being tested: Bepirovirsen
Keywords: Hepatitis B, Hepatitis, Viral, Human, Virus Diseases, Bepirovirsen, GSK3228836, 219239, Liver Diseases
Medical subject headings: Hepatitis B, Hepatitis, Virus Diseases, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BepirovirsenDrug
Bepirovirsen will be administered.

Study groups in NCT06058390
Study group	Role	What they receive
Bepirovirsen Vial by HCP	Experimental	Participants will receive Bepirovirsen vial administered by Healthcare Professionals (HCP). Receives: Drug: Bepirovirsen
Bepirovirsen PFS SSD by HCP	Experimental	Participants will receive Bepirovirsen PFS SSD administered by HCP. Receives: Drug: Bepirovirsen
Bepirovirsen PFS SSD self-administered post-training	Experimental	Participants will receive Bepirovirsen PFS SSD self- administered with training by HCP. Receives: Drug: Bepirovirsen
Bepirovirsen PFS SSD self-administered without training	Experimental	Participants will receive Bepirovirsen PFS SSD self- administered with no training by HCP. Receives: Drug: Bepirovirsen

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using Vial and PFS by HCP
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. Pharmacokinetic (PK) Parameter Population included all participants in the PK concentration Population for whom valid and evaluable plasma PK parameters were derived.
Measured: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC [0-Inf]) Following Administration of Bepirovirsen Using Vial and PFS by HCP
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Measured: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)

Secondary outcomes (4)

Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Measured: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
AUC(0-inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Measured: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Measured: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
AUC(0-Inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Measured: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 20233 May 2024

First posted28 Sep 2023
Study start4 Oct 2023
Primary completion3 May 2024
Study completion3 May 2024

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 (2)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: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06058390
Sponsor's protocol ID: 219239
Status last verified: Jun 2025
First submitted: 22 Sep 2023
Last updated: 18 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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
Youssef AS, Shah P, Hu M, Plein H, Roy A, Sharma R, Mole S, Blazejczyk M, Cross W, Spears B, Pak S, Kaur R, Elston R, Theodore D, Hezareh M, Nader A. A Phase 1, Randomized, Open-Label, Parallel Group Study to Evaluate the Relative Bioavailability and Safety of Subcutaneous Bepirovirsen when Delivered from a Vial or Prefilled Syringe Fitted with a Safety Syringe Device in Healthy Adult Participants. Clin Pharmacol Drug Dev. 2026 Feb;15(2):e1615. doi: 10.1002/cpdd.1615. Epub 2025 Oct 14.
PubMed 41085094

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-Label, Parallel Group Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants
ClinicalTrials.gov ID: NCT06058390
Acronym / sponsor ID: 219239
Conditions: Hepatitis B
Keywords: Hepatitis B, Hepatitis, Viral, Human, Virus Diseases, Bepirovirsen, GSK3228836, 219239
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 4 Oct 2023 (actual)
Primary completion: 3 May 2024 (actual)
Study completion: 3 May 2024 (actual)
First posted: 28 Sep 2023 (actual)
Results: Posted 18 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Bepirovirsen Vial by HCP	Experimental	Drug: BepirovirsenParticipants will receive Bepirovirsen vial administered by Healthcare Professionals (HCP).
Bepirovirsen PFS SSD by HCP	Experimental	Drug: BepirovirsenParticipants will receive Bepirovirsen PFS SSD administered by HCP.
Bepirovirsen PFS SSD self-administered post-training	Experimental	Drug: BepirovirsenParticipants will receive Bepirovirsen PFS SSD self- administered with training by HCP.
Bepirovirsen PFS SSD self-administered without training	Experimental	Drug: BepirovirsenParticipants will receive Bepirovirsen PFS SSD self- administered with no training by HCP.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy participants as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECGs) and vital signs.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and protocol.

Key exclusion criteria (16 listed)

Past or current medical conditions which, in the judgement of the investigator and Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant.
Abnormal blood pressure as determined by the investigator.
Positive Hepatitis B virus (HBV), Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test results.
Participants with signs or symptoms suggestive of Coronavirus disease 2019 (COVID-19) within 14 days of inpatient admission, or with a positive test for active COVID-19 infection before study start.
Past, current or intended use of over the counter or prescription medication [including herbal medications]

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 will be administered.	Drug	Bepirovirsen PFS SSD by HCP, Bepirovirsen PFS SSD self-administered post-training, Bepirovirsen PFS SSD self-administered without training, Bepirovirsen Vial by HCP

Primary outcome

Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using Vial and PFS by HCP
Time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. Pharmacokinetic (PK) Parameter Population included all participants in the PK concentration Population for whom valid and evaluable plasma PK parameters were derived.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC [0-Inf]) Following Administration of Bepirovirsen Using Vial and PFS by HCP
Time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.

4 secondary outcomes

Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training
Time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
AUC(0-inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training
Time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training
Time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
AUC(0-Inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training
Time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)

Results and safety

Results posted to the registry on 18 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bepirovirsen 300 mg Vial by HCP	46	46
Bepirovirsen 300 mg PFS SSD by HCP	49	49
Bepirovirsen 300 mg PFS SSD Self-administered Post-training	32	30
Bepirovirsen 300 mg PFS SSD Self-administered Without Training	33	30

Primary outcome: Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using Vial and PFS by HCP

Time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours). Geometric mean (Standard Error). Unit: Nanograms per milliliters (ng/mL)

Measure	Bepirovirsen 300 mg Vial by HCP n = 46	Bepirovirsen 300 mg PFS SSD by HCP n = 49
Value	9954.89 (0.049)	10163.74 (0.048)

Bepirovirsen 300 mg Vial by HCP vs Bepirovirsen 300 mg PFS SSD by HCP: Geometric mean ratio: 1.02 (90% CI 0.91 to 1.14)

Population analysed: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD by HCP and reference group is Bepirovirsen 300 mg Vial by HCP for this outcome measure. Based on the test and reference, data was analyzed and Cmax values were modelled as described in measure description which vary across different outcome measures.

Primary outcome: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC [0-Inf]) Following Administration of Bepirovirsen Using Vial and PFS by HCP

Measure	Bepirovirsen 300 mg Vial by HCP n = 46	Bepirovirsen 300 mg PFS SSD by HCP n = 49
Value	112495.66 (0.039)	118622.59 (0.038)

Bepirovirsen 300 mg Vial by HCP vs Bepirovirsen 300 mg PFS SSD by HCP: Geometric mean ratio: 1.05 (90% CI 0.96 to 1.15)

Population analysed: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD by HCP and reference group is Bepirovirsen 300 mg Vial by HCP for this outcome measure. Based on the test and reference, data was analyzed and AUC(0-inf) values were modelled as described in measure description which vary across different outcome measures.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bepirovirsen 300 mg Vial by HCP	0 of 46 (0%)	45 of 46 (97.8%)	0 of 46
Bepirovirsen 300 mg PFS SSD by HCP	0 of 49 (0%)	43 of 49 (87.8%)	0 of 49
Bepirovirsen 300 mg PFS SSD Self-administered Post-training	0 of 32 (0%)	32 of 32 (100%)	0 of 32
Bepirovirsen 300 mg PFS SSD Self-administered Without Training	0 of 32 (0%)	30 of 32 (93.8%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
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.
Derived from this study: PubMed 41085094Youssef AS, Shah P, Hu M, Plein H, Roy A, Sharma R, Mole S, Blazejczyk M, Cross W, Spears B, Pak S, Kaur R, Elston R, Theodore D, Hezareh M, Nader A. A Phase 1, Randomized, Open-Label, Parallel Group Study to Evaluate the Relative Bioavailability and Safety of Subcutaneous Bepirovirsen when Delivered from a Vial or Prefilled Syringe Fitted with a Safety Syringe Device in Healthy Adult Participants. Clin Pharmacol Drug Dev. 2026 Feb;15(2):e1615. doi: 10.1002/cpdd.1615. Epub 2025 Oct 14.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Related trials for Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
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Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
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Chronic Hepatitis B

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

2 sites 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 2 sites 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 2 inclusion and 16 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 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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 18 Jul 2025). 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?

Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using Vial and PFS by HCP (time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)). The study lists 2 primary outcomes in all. 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 NCT06058390, which also lists 2 linked publications.

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 18 Jul 2025.