Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 28, 2019

Primary Completion Date

January 14, 2020

Study Completion Date

January 14, 2020

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

Belimumab for IV

Belimumab will be available as white to off-white lyophilized cake at a unit dose strength of 400 mg to be reconstituted and diluted in normal saline to obtain 200 mg per dose.

DRUG

Belimumab for SC

Belimumab will be available as clear to opalescent, colorless to pale yellow sterile solution at unit dose strength of 200 mg/milliliter (mg/mL) for SC injection in a single-use, prefilled syringe contained within an auto-injector device.

Trial Locations (1)

201508

GSK Investigational Site, Shanghai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT04136145 - Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects | Biotech Hunter | Biotech Hunter