Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT06058390 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 160 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (167% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as e
Interventions
- DRUG Bepirovirsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2023-10-04 |
| Est. Completion | 2024-05-03 |
| Phase | Phase 1 |
What the finished NCT06058390 record still lists
NCT06058390 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (167% higher).
The record links to 0 conditions, and to 1 intervention - of which Bepirovirsen is the first listed.
NCT06058390 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06058390's enrollment target sits among peer trials
160 340th of 2000 higher than 1,655 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00501826 · 160 participants · Phase 2
Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- NCT00932139 · 160 participants · NA
Effect of Electro-Acupuncture on Blood Pressure
- NCT00992901 · 160 participants · Early Phase 1
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
- NCT01515527 · 160 participants · Phase 2
Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI