246
Participants
Start Date
January 6, 2017
Primary Completion Date
August 11, 2017
Study Completion Date
August 11, 2017
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.
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.
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.
Prefilled Safety Syringe
Single use, disposable safety syringe with a retracting needle guard and locking system.
GSK Investigational Site, Berlin
GSK Investigational Site, Baltimore
GSK Investigational Site, Harrow
Lead Sponsor
GlaxoSmithKline
INDUSTRY