Evidence map›Paper›PMID 41085094›Full record

Trial reportClinical pharmacology in drug development2026

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.

Amir S Youssef, Poonam Shah, Maxwell Hu, Helene Plein, Abhishek Roy, Ravi Sharma, Sarah Mole, Magdalena Blazejczyk, Wendy Cross, Brian Spears and 6 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology in drug development, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Amir S YoussefClinical Pharmacology and Quantitative Medicine, GSK, Collegeville, Pennsylvania, USA.
Poonam ShahClinical Development, GSK, Stevenage, UK.
Maxwell HuResearch and Development, GSK, Shanghai, China.
Helene PleinSafety Evaluation and Risk Management, GSK, London, UK.
Abhishek RoyDevelopment Biostatistics, GSK, Bangalore, India.
Ravi SharmaDevelopment Biostatistics, GSK, Warsaw, Poland.
Sarah MoleClinical Development, GSK, Stevenage, UK.
Magdalena BlazejczykSafety Evaluation and Risk Management, GSK, Warsaw, Poland.
Wendy CrossMedicine Development Industrialisation, GSK, Stevenage, UK.
Brian SpearsClinical Research - Early Clinical Development, PPD, Austin, Texas, USA.
Samuel PakClinical Research - Early Clinical Development, PPD, Las Vegas, Nevada, USA.
Rejbinder KaurDevelopment Global Clinical Operations, GSK, Stevenage, UK.
Robert ElstonClinical Development, GSK, Stevenage, UK.
Dickens TheodoreClinical Development, GSK, Durham, North Carolina, USA.
Marjan HezarehClinical Development, GSK, London, UK.
Ahmed NaderClinical Pharmacology and Quantitative Medicine, GSK, Collegeville, Pennsylvania, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Bepirovirsen, an antisense oligonucleotide in development for the treatment of chronic hepatitis B virus (HBV) infection, is administered from glass vials as a subcutaneous (SC) injection by healthcare professionals (HCPs). A ready-to-use prefilled syringe (PFS) assembled with a safety syringe device (SSD) has been developed to make administration more convenient and facilitate patient self-administration. This Phase 1, open-label, randomized, parallel-group study evaluated the relative bioavailability of bepirovirsen delivered from a vial or PFS SSD, assessed the viability of PFS SSD self-administration, and evaluated the safety and tolerability of SC bepirovirsen in healthy participants. Participants (N = 159) received a single 300 mg SC dose of bepirovirsen administered by a HCP (vial [n = 46] or PFS SSD [n = 49]), or self-administered (PFS SSD, with [n = 32] or without [n = 32] training from a HCP). Relative bioavailability (primary endpoint) of HCP-administered bepirovirsen delivered by vial versus PFS SSD was assessed using maximum observed plasma concentration (C

Indexed as

Antiviral AgentsSyringesAdultBiological AvailabilityFemaleHealthy VolunteersHumansInjections, SubcutaneousMaleMiddle AgedSelf AdministrationTherapeutic EquivalencyYoung AdultAntiviral Agentsantisense oligonucleotidechronic hepatitis BHBV DNApharmacokineticsself‐administration

Identifiers

PMID41085094
PMCPMC12856967

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.