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NCT03014674 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare the Pharmacokinetics of Mepolizumab as a Liquid Drug in a Safety Syringe or an Autoinjector Versus Lyophilised Drug
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 246
- Enrollment target
NCT03014674: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT03014674 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 246 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03014674, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 246 participants
- Enrollment target
Study Summary
Mepolizumab (SB-240563) is a humanized monoclonal antibody (Immunoglobulin G1, kappa, mAb) that blocks human interleukin-5 (hIL-5) from binding to the interleukin (IL)-5 receptor complex expressed on the eosinophil cell surface and thus inhibits signaling. This study will compare the pharmacokinetics and safety of mepolizumab administered as a liquid drug product in two different devices with the reconstituted lyophilized drug product in healthy subjects. Subjects will receive a single administration of 100 milligram (mg) mepolizumab as a single injection. The randomization will be stratified by body weight (\<70 kilogram (kg), 70 \<80 kg and \>=80 kg) and the site of injection will be randomized 1:1:1 to the upper arm, abdomen or thigh. Approximately 243 healthy subjects will be randomized so that at least 9 subjects are randomized to each mepolizumab treatment within each weight strata and 3 subjects within each mepolizumab treatment, weight strata and injection site. Each subject will participate in the study for up to approximately 16 weeks (up to 85 days after drug administration), and will have a screening visit, a single dose treatment period, and a follow-up visit.
Primary Outcome
Blood samples were collected at indicated time points. Cmax following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with reconstituted lyophilized drug product from the vial. Pharmacokinetic (PK) Population comprised of all participants receiving study drug for whom a pharmacokinetic sample was obtained and analyzed.
Interventions
- BIOLOGICAL Lyophilized mepolizumab
- BIOLOGICAL Liquid mepolizumab
- DEVICE Prefilled autoinjector
- DEVICE Prefilled Safety Syringe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2017-01-06 |
| Est. Completion | 2017-08-11 |
| Phase | Phase 3 |
What the finished NCT03014674 record still lists
NCT03014674 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 4 interventions - of which Lyophilized mepolizumab is the first listed.
NCT03014674 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03014674 about?
NCT03014674 is a clinical study titled "A Study to Compare the Pharmacokinetics of Mepolizumab as a Liquid Drug in a Safety Syringe or an Autoinjector Versus Lyophilised Drug". Mepolizumab (SB-240563) is a humanized monoclonal antibody (Immunoglobulin G1, kappa, mAb) that blocks human interleukin-5 (hIL-5) from binding to the interleukin (IL)-5 receptor complex expressed on the eosinophil cell surface and thus inhibits signaling. This study will compare the pharmacokinetic...
What is the current status of trial NCT03014674?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 246 participants. The study started on 2017-01-06. Estimated completion is 2017-08-11.
What interventions are being tested in trial NCT03014674?
The interventions under investigation include: Lyophilized mepolizumab (BIOLOGICAL), Liquid mepolizumab (BIOLOGICAL), Prefilled autoinjector (DEVICE), Prefilled Safety Syringe (DEVICE).
Who is sponsoring clinical trial NCT03014674?
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 NCT03014674's enrollment target sits among peer trials
246 1267th of 2000 higher than 734 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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