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

Phase 1 Completed 160 enrolled GlaxoSmithKline

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2023-10-04
Primary completion: 2024-05-03
Completion: 2024-05-03

Outcome

Met primary endpoint

paper for both Cmax (1.02 [0.91-1.14]) and AUC(0-inf) (1.05 [0.96-1.15]). PMID 41085094 ↗

paper the 90% confidence intervals (CIs) for the geometric mean ratios (GMRs) were within the standard bioequivalence reference range, 0.80-1.25 PMID 41085094 ↗

Publications

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. 2026 Feb;15(2):e1615. doi: 10.1002/cpdd.1615. Epub 2025 Oct 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bepirovirsen	Antisense oligonucleotide	300 mg	Subcutaneous