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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 246 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03014674
The ClinicalTrials.gov registry entry for NCT03014674 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 246 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 4 interventions - of which Lyophilized mepolizumab is the first listed.
NCT03014674 reports 0 study locations.
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.
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