Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus
Status:
Completed
Trial end date:
2017-09-08
Target enrollment:
Participant gender:
Summary
In China, Belimumab (GSK1550188) will be developed for a dosing regimen of once-monthly
intravenous (IV) infusion for the treatment of SLE. This open-label, single dose study will
evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of
belimumab in Chinese SLE subjects. A total of approximately 20 subjects will be enrolled to
receive IV infusion of 10 milligrams per kilogram (mg/kg) GSK1550188 on Day 0 for the
treatment of SLE. Subjects will be followed for 84 days after the administration of drug.