A Study to Compare the Pharmacokinetics of Mepolizumab as a Liquid Drug in a Safety Syringe or an Autoinjector Versus Lyophilised Drug

PHASE3CompletedINTERVENTIONAL
Enrollment

246

Participants

Timeline

Start Date

January 6, 2017

Primary Completion Date

August 11, 2017

Study Completion Date

August 11, 2017

Conditions
Asthma
Interventions
BIOLOGICAL

Lyophilized mepolizumab

Mepolizumab will be provided as white, uniform, lyophilized cake in vials with unit dose strength of 100 mg/vial for reconstitution in 1.2 mL sterile water for injection (SWFI). Following reconstitution it forms a clear to opalescent, colorless to pale yellow solution for SC injection.

BIOLOGICAL

Liquid mepolizumab

Mepolizumab will be provided as a clear to opalescent, colorless to pale yellow sterile solution for SC injection, supplied in a single-use, prefilled autoinjector or safety syringe containing 100 mg/mL mepolizumab with sodium phosphate, citric acid, sucrose ethylenediaminetetraacetic acid and polysorbate 80.

DEVICE

Prefilled autoinjector

Single use, disposable autoinjector will be assembled with the prefilled syringe containing the drug product. It will enable automatic delivery of the drug product under the power of a spring mechanism following activation of the device. Start and end of injection clicks will inform the user of correct use. A plastic needle will cover shield the needle before and after injection to minimize the potential for needle stick injuries.

DEVICE

Prefilled Safety Syringe

Single use, disposable safety syringe with a retracting needle guard and locking system.

Trial Locations (3)

14050

GSK Investigational Site, Berlin

21225

GSK Investigational Site, Baltimore

HA1 3UJ

GSK Investigational Site, Harrow

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY