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NCT01894360 · ClinicalTrials.gov registry record · Phase 1
A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT01894360 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 81 participants.
The verdict
NCT01894360, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
This will be a randomized, parallel-group, open-label, single-dose study of belimumab in healthy subjects to estimate the relative bioavailability, tolerability and safety of a single dose of belimumab 200 milligram (mg) when self-administered SC by healthy subjects using a prefilled syringe or autoinjector. This study will also assess the usability and reliability of the injection devices. A total of approximately 80 subjects (40 per group) will be randomly assigned in a 1 to 1 ratio to receive 200 mg belimumab SC as a single 1.0 milliliter (mL) injection of the liquid formulation (200 mg/mL) on Day 0 via the assigned injection device. Subjects will continue to be followed for 70 days after the administration of belimumab.
Interventions
- DRUG Belimumab 200 mg/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2013-10-14 |
| Est. Completion | 2014-05-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01894360
The ClinicalTrials.gov registry entry for NCT01894360 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 81 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 Belimumab 200 mg/mL is the first listed.
NCT01894360 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01894360 about?
NCT01894360 is a clinical study titled "A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy Subjects". This will be a randomized, parallel-group, open-label, single-dose study of belimumab in healthy subjects to estimate the relative bioavailability, tolerability and safety of a single dose of belimumab 200 milligram (mg) when self-administered SC by healthy subjects using a prefilled syringe or auto...
What is the current status of trial NCT01894360?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2013-10-14. Estimated completion is 2014-05-13.
What interventions are being tested in trial NCT01894360?
The interventions under investigation include: Belimumab 200 mg/mL (DRUG).
Who is sponsoring clinical trial NCT01894360?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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