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Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus
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.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | Mon Jan 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Sep 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Systemic Lupus Erythematosus
Interventions
- Belimumab
Countries
China