Last updated: 10/24/2025 09:50:07
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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Maximum Observed Concentration (Cmax) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants
Timeframe: Up to Day 64
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants
Timeframe: Up to Day 64
Secondary outcomes:
Maximum Observed Concentration of Plasma Bepirovirsen in Group 2 vs Group 3 Participants
Timeframe: Up to Day 64
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 2 vs Group 3 Participants
Timeframe: Up to Day 64
Maximum Observed Concentration of Plasma Bepirovirsen in Group 2 vs Group 4 Participants
Timeframe: Up to Day 64
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 2 vs Group 4 Participants
Timeframe: Up to Day 64
Interventions:
Enrollment:
160
Primary completion date:
2024-03-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Amir S Youssef, Poonam Shah, Maxwell Hu, Helene Plein, Abhishek Roy, Ravi Sharma, Sarah Mole, Magdalena Blazejczyk, Wendy Cross, Brian Spears, Samuel Pak, Rejbinder Kaur, Robert Elston, Dickens Theodore, Marjan Hezareh, Ahmed Nader. 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. Clinical pharmacology in drug development. 2025-Oct-14; doi:10.1002/cpdd.1615 http://dx.doi.org/10.1002/cpdd.1615
https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.1615
PMID: 41085094
DOI: 10.1002/cpdd.1615
Medical condition
Hepatitis B
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2023 to May 2024
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 Years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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. 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 location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2024-03-05
Actual study completion date
2024-03-05
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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