Hepatitis BPhase 1NCT07905157
A Study to Compare Blood Levels of Bepirovirsen and Safety Using Different Methods of Injecting in Healthy Adult Participants
A Phase 1 study testing Bepirovirsen in people with Hepatitis B, run by GlaxoSmithKline.
Trial summary
This is an open-label study being done to compare two different methods of study medicine bepirovirsen is given in healthy adults. The researchers want to learn how the body affects the medicine over time (pharmacokinetic [PK] study). Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 98 participants
- Where
- No sites listed yet
- Study dates
- 3 Nov 2026to 30 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than or equal to (>=) 18 and less than or equal to (<=) 65 years 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 (ECGs) and vital signs.
- Body weight >=50 kilograms (kg) and body mass index (BMI) >= 19.0 to 29.9 kilograms per square meter (kg/m^2).
- Male and female participants, as follows:
- Male Participants: There are no contraceptive requirements for male participants.
- A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
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- Is a participant of non-childbearing potential (PONCBP), or
- Is a participant of childbearing potential (POCBP) and using an acceptable contraceptive method 28 days prior to and during the study intervention period and for at least 16 weeks after the last dose of study intervention. The Investigator should evaluate the potential for contraceptive method failure (for example, non-compliance, recently initiated in relationship to the first dose of study intervention).
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
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.
- Abnormal blood pressure, as determined by the investigator.
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Participants with any other medical conditions which, in the judgement of the investigator (or in consultation with the Medical Monitor), could jeopardize the integrity of the safety of the participant or the data derived from that participant.
- Current or chronic history of liver disease, hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- 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.
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- 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 ribonucleic acid (siRNA) within 12 months before dosing
- Participants for whom immunosuppressive treatment, including therapeutic doses of steroids, is contraindicated.
- Participants requiring anti-coagulation therapies (e.g., warfarin, Factor Xa inhibitors) or anti-platelet agents (including but not limited to clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of study intervention, by the discretion of the investigator. Occasional use is permitted.
- Prior treatment with bepirovirsen.
- Prior/Concurrent clinical study participation:
- Loss of blood or blood products in excess of 500 milliliters (mL) within any 3-month period during the study.
- Exposure to more than 4 new drugs within 12 months prior to the first dosing day.
- The participant has participated in a clinical trial and has received an investigational product within the following time period prior to dosing in the current study: 5 half-lives (if known) or twice the duration (if known) of the biological effect of the study intervention (whichever is longer) or 90 days (if half-life or duration is unknown), or, current participation in another clinical study
- Enrollment into another clinical study whilst participating in this study.
- Diagnostic assessments:
- Positive pre-study drug/alcohol screen, including tetrahydrocannabinol (THC).
- Cotinine levels indicative of regular or recent use of tobacco products or nicotine-containing products, including cigarettes, cigars, pipes and materials used to 'vape 'Positive Human Immunodeficiency Virus (HIV) antibody test.
- Liver safety:
- Alanine transaminase (ALT) >1.5 × upper limit of normal (ULN).
- Total bilirubin >1.5 × ULN (isolated total bilirubin >1.5 × ULN is acceptable if total bilirubin is fractionated and direct bilirubin < 35 percent (%). Participants with Gilbert's syndrome can be included with total bilirubin >1.5xULN if direct bilirubin is <= 1.5xULN.
- For participants with benign unconjugated hyperbilirubinemia with total bilirubin >1.25 × ULN, the investigator should review the results in conjunction with other medical history to confirm eligibility.
- Serum albumin <=3.5 gram per deciliter (g/dL).
- Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
- Note: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C RNA test is obtained.
- Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
- Note: Test is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.
- Cardiac Safety:
- Corrected QT interval (QTc) QTcF >= 450 milliseconds (msec) (mean of triplicate measurements should be used at screening to confirm that participant meets exclusion criterion
- Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of >14 units for males or females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- Others:
- Regular use of known drugs of abuse, including tetrahydrocannabinol (THC).
- Sensitivity to heparin or heparin-induced thrombocytopenia.
- Sensitivity or history of sensitivity to the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator [or medical monitor] contraindicates participation in the clinical study.
- Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.).
- Platelets <140x10^9/L.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Randomized, Open-Label, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics and Safety of Bepirovirsen When Delivered From a Vial or a 1ml Autoinjector in Healthy Adult Participants
This is an open-label study being done to compare two different methods of study medicine bepirovirsen is given in healthy adults. The researchers want to learn how the body affects the medicine over time (pharmacokinetic [PK] study). The study will also evaluate the safety of bepirovirsen and how well it is tolerated, meaning how people feel after receiving the medicine and whether they experience any side effects.
- Conditions
- Hepatitis B
- Being tested
- Bepirovirsen
- Keywords
- Bepirovirsen, Hepatitis B virus, Liver Diseases, Infectious Diseases, Pharmacokinetics, Administration, Safety, Autoinjector
- Medical subject headings
- Hepatitis B, Liver Diseases, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BepirovirsenDrug
Also called GSK3228836
Bepirovirsen will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Bepirovirsen will be administered from a vial. Receives: Drug: Bepirovirsen |
| Group 2 | Experimental | Bepirovirsen will be administered from an autoinjector. Receives: Drug: Bepirovirsen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time Curve from Time Zero (pre-dose) up to Day 8 [AUC(0- 8 d)] of Bepirovirsen in Plasma
Measured: Pre-dose to Day 8 (168 hours) post dose
Maximum Observed Concentration (Cmax) of Bepirovirsen in plasma
Measured: Pre-dose to Day 8 (168 hours) post dose
Secondary outcomes (3)
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs Related SAEs
Measured: Up to 64 Days
Number of Participants with Fatal SAEs, AEs of Grade 3 and above, and AEs Leading to Permanent Discontinuation of Study Intervention
Measured: Up to 64 Days
Number of Participants with Adverse Event of Special Interest (AESIs)
Measured: Up to 64 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start3 Nov 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905157
- Sponsor's protocol ID
- 306775
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics and Safety of Bepirovirsen When Delivered From a Vial or a 1ml Autoinjector in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07905157
- Acronym / sponsor ID
- 306775
- Conditions
- Hepatitis B
- Keywords
- Bepirovirsen, Hepatitis B virus, Liver Diseases, Infectious Diseases, Pharmacokinetics, Administration, Safety, Autoinjector
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label study being done to compare two different methods of study medicine bepirovirsen is given in healthy adults. The researchers want to learn how the body affects the medicine over time (pharmacokinetic [PK] study). The study will also evaluate the safety of bepirovirsen and how well it is tolerated, meaning how people feel after receiving the medicine and whether they experience any side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: BepirovirsenBepirovirsen will be administered from a vial. |
| Group 2 | Experimental | Drug: BepirovirsenBepirovirsen will be administered from an autoinjector. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age greater than or equal to (>=) 18 and less than or equal to (<=) 65 years 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 (ECGs) and vital signs.
- Body weight >=50 kilograms (kg) and body mass index (BMI) >= 19.0 to 29.9 kilograms per square meter (kg/m^2).
- Male and female participants, as follows:
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
Key exclusion criteria (38 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.
- Abnormal blood pressure, as determined by the investigator.
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Participants with any other medical conditions which, in the judgement of the investigator (or in consultation with the Medical Monitor), could jeopardize the integrity of the safety of the participant or the data derived from that participant.
- Current or chronic history of liver disease, hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
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 |
|---|---|---|
| BepirovirsenAlso: GSK3228836Bepirovirsen will be administered. | Drug | Group 1, Group 2 |
Primary outcome
Area Under the Concentration-time Curve from Time Zero (pre-dose) up to Day 8 [AUC(0- 8 d)] of Bepirovirsen in Plasma
Time frame: Pre-dose to Day 8 (168 hours) post dose
Maximum Observed Concentration (Cmax) of Bepirovirsen in plasma
Time frame: Pre-dose to Day 8 (168 hours) post dose
3 secondary outcomes
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs Related SAEs
Time frame: Up to 64 Days
Number of Participants with Fatal SAEs, AEs of Grade 3 and above, and AEs Leading to Permanent Discontinuation of Study Intervention
Time frame: Up to 64 Days
Number of Participants with Adverse Event of Special Interest (AESIs)
Time frame: Up to 64 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- 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
Related trials for Hepatitis B
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bepirovirsen in people with Hepatitis B, run by GlaxoSmithKline.
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 9 inclusion and 38 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-time Curve from Time Zero (pre-dose) up to Day 8 [AUC(0- 8 d)] of Bepirovirsen in Plasma (time frame: Pre-dose to Day 8 (168 hours) post dose). 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?
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 29 Oct 2026.