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This will be a randomized, parallel-group, open-label, single-dose study of belimumab in healthy subjects to estimate the relative bioavailability, tolerability and safety of a single dose of belimumab 200 milligram (mg) when self-administered SC by healthy subjects using a prefilled syringe or autoinjector. This study will also assess the usability and reliability of the injection devices. A total of approximately 80 subjects (40 per group) will be randomly assigned in a 1 to 1 ratio to receive 200 mg belimumab SC as a single 1.0 milliliter (mL) injection of the liquid formulation (200 mg/mL) on Day 0 via the assigned injection device. Subjects will continue to be followed for 70 days after the administration of belimumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belimumab 200 mg/mL, prefilled syringe | Experimental | Subjects will be randomly assigned in a 1 to 1 ratio to receive a single dose of 200 mg belimumab SC (1.0 mL injection) via prefilled syringe on Day 0. |
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| Belimumab 200 mg/mL, Autoinjector | Experimental | Subjects will be randomly assigned in a 1 to 1 ratio to receive a single dose of 200 mg belimumab SC (1.0 mL injection) via prefilled syringe contained within an autoinjector device on Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab 200 mg/mL | Drug | Clear to opalescent, colorless to pale yellow sterile solution sterile solution for SC injection in a single-use liquid formulation of Belimumab 200 mg/mL will be supplied in 1mL long glass prefilled syringe or autoinjector device. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PK assessment for Cmax, AUC(0-t), AUC(0-inf) | Blood sample will be collected for estimation of relative bioavailability and assessment of PK parameters including maximum observed concentration; Cmax, area under the concentration-time curve from time 0 to time t; AUC(0-t) and area under the concentration-time curve from time 0 to infinity; AUC(0-inf) | From Baseline upto Day 70 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessment including Adverse events (AEs), serious adverse events (SAEs), changes in laboratory values, and vital signs | Safety measurements will be assessed for AEs and SAEs, clinical laboratory parameters including Clinical hematology, chemistry, serum immunoglobulin isotypes and urinalysis. Vital signs measurements including temperature, systolic and diastolic blood pressure, pulse rate and respiratory rate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Overland Park | Kansas | 66211 | United States |
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| Label | URL |
|---|---|
| Results for study 117100 can be found on the GSK Clinical Study Register. | View source |
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 117100 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| From Screening upto Day 70 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 117100 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117100 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117100 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117100 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117100 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117100 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C511911 | belimumab |
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