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

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
GlaxoSmithKline
Study ID
NCT06058390
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 4, 2023
Status verified
Jun 2025
Primary completion
May 3, 2024
Completion
May 3, 2024

Study Design

Enrollment
160 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bepirovirsen Vial by HCP
    Participants will receive Bepirovirsen vial administered by Healthcare Professionals (HCP).
  • Experimental: Bepirovirsen PFS SSD by HCP
    Participants will receive Bepirovirsen PFS SSD administered by HCP.
  • Experimental: Bepirovirsen PFS SSD self-administered post-training
    Participants will receive Bepirovirsen PFS SSD self- administered with training by HCP.
  • Experimental: Bepirovirsen PFS SSD self-administered without training
    Participants will receive Bepirovirsen PFS SSD self- administered with no training by HCP.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using Vial and PFS by HCP [ Time Frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) ]

Locations (2)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLas VegasNevada89113-
GSK Investigational SiteAustinTexas78744-

Find similar trials in Las Vegas, NV

By research site
GSK Investigational Site· Las Vegas, NVGSK Investigational Site· Austin, TX

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