Sign in

NCT06058390CompletedPhase 1

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, 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

Source: ClinicalTrials.gov · Last updated 18 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
160 (actual)
First submitted
22 Sept 2023
Start date
4 Oct 2023
Primary completion date
3 May 2024
Lead sponsor
GlaxoSmithKline
Diseases
Hepatitis B
NCT number
NCT06058390

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 160
  • From 4 Oct 2023 to the primary completion date, 3 May 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.
  • 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).

Other illness

  • 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.
  • 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.
  • 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.

Other

  • Abnormal blood pressure as determined by the investigator.
  • Loss of blood or blood products in excess of 500 millilitre (mL) within any 3-month period during the study.
  • Current enrolment or past participation in this clinical study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Las VegasUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.