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NCT06058390 · ClinicalTrials.gov registry record · Phase 1
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 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 160
- Enrollment target
NCT06058390 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 160 participants.
The verdict
NCT06058390, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 160 participants
- Enrollment target
Study 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.
Interventions
- DRUG Bepirovirsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2023-10-04 |
| Est. Completion | 2024-05-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06058390
The ClinicalTrials.gov registry entry for NCT06058390 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bepirovirsen is the first listed.
NCT06058390 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06058390 about?
NCT06058390 is a clinical study titled "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". 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 suppo...
What is the current status of trial NCT06058390?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2023-10-04. Estimated completion is 2024-05-03.
What interventions are being tested in trial NCT06058390?
The interventions under investigation include: Bepirovirsen (DRUG).
Who is sponsoring clinical trial NCT06058390?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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