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NCT06058390

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
GlaxoSmithKline·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Hepatitis B
Drug/Device/Intervention
Bepirovirsen
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GlaxoSmithKline
Location
Las Vegas,Austin, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Sep 26, 2023
End date
May 30, 2024
Enrollment
200 participants
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
Acute hepatitis BAcute hepatitis B without delta-agent and without hepatic comaAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agentChronic viral hepatitis B without delta-agent : other and unspecified phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06058390
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.