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 - Trial NCT06058390
Access comprehensive clinical trial information for NCT06058390 through Pure Global AI's free database. This Phase 1 trial is sponsored by GlaxoSmithKline and is currently Not yet recruiting. The study focuses on Hepatitis B. Target enrollment is 200 participants.
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Study Focus
Sponsor & Location
GlaxoSmithKline
Timeline & Enrollment
Phase 1
Sep 26, 2023
May 30, 2024
Primary Outcome
Maximum Observed Concentration (Cmax) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants,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
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06058390
Non-Device Trial