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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: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01894360 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood sample will be collected for estimation of relative bioavailability and assessment of PK parameters including maximum observed concentration; Cmax, area under the concentration-time curve from time 0 to time t; AUC(0-t) and area under the concentration-time curve from time 0 to infinity; AUC(0-inf)
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 |
What the finished NCT01894360 record still lists
NCT01894360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 1 intervention - of which Belimumab 200 mg/mL is the first listed.
NCT01894360 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01894360's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 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
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