Last updated: 10/24/2026 02:42:04
A Study to Compare Blood Levels of Bepirovirsen and Safety Using Different Methods of Injecting in Healthy Adult Participants
GSK study ID
306775
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not yet recruiting
Not yet recruiting
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Area Under the Concentration-time Curve from Time Zero (pre-dose) up to Day 8 [AUC(0- 8 d)] of Bepirovirsen in Plasma
Timeframe: Pre-dose to Day 8 (168 hours) post dose
Maximum Observed Concentration (Cmax) of Bepirovirsen in plasma
Timeframe: Pre-dose to Day 8 (168 hours) post dose
Secondary outcomes:
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs Related SAEs
Timeframe: 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
Timeframe: Up to 64 Days
Number of Participants with Adverse Event of Special Interest (AESIs)
Timeframe: Up to 64 Days
Interventions:
Drug: Bepirovirsen
Enrollment:
98
Primary completion date:
2027-30-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Bepirovirsen
Collaborators
Not applicable
Study date(s)
November 2026 to March 2027
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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).
- 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.
Male and female participants, as follows: o Male Participants: There are no contraceptive requirements for male participants. o A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
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.
- 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.
- 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 location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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