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

NCT ID: NCT06058390

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-04
• Study Completion Date: 2024-05-03

Brief Summary

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bepirovirsen Vial by HCP

Participants will receive Bepirovirsen vial administered by Healthcare Professionals (HCP).

Group Type: EXPERIMENTAL

Bepirovirsen

Intervention Type: DRUG

Bepirovirsen will be administered.

Bepirovirsen PFS SSD by HCP

Participants will receive Bepirovirsen PFS SSD administered by HCP.

Group Type: EXPERIMENTAL

Bepirovirsen

Intervention Type: DRUG

Bepirovirsen will be administered.

Bepirovirsen PFS SSD self-administered post-training

Participants will receive Bepirovirsen PFS SSD self- administered with training by HCP.

Group Type: EXPERIMENTAL

Bepirovirsen

Intervention Type: DRUG

Bepirovirsen will be administered.

Bepirovirsen PFS SSD self-administered without training

Participants will receive Bepirovirsen PFS SSD self- administered with no training by HCP.

Group Type: EXPERIMENTAL

Bepirovirsen

Intervention Type: DRUG

Bepirovirsen will be administered.

Interventions

Bepirovirsen

Bepirovirsen will be administered.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Austin, Texas, United States

Countries

United States

References

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. 2025 Oct 14. doi: 10.1002/cpdd.1615. Online ahead of print.

Reference Type: DERIVED

PMID: 41085094 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

219239

Identifier Type: -

Identifier Source: org_study_id