The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Single IV or SC dose of SBI-087
Arthritis & Rheumatology Care Center
South Miami, Florida, United States
Miami Research Associates
South Miami, Florida, United States
MRA Clinical Research
South Miami, Florida, United States
Duke University Medical Center
Durham, North Carolina, United States
Safety (physical examinations, laboratory tests, adverse events) and tolerability (dose-limiting toxicities) of ascending single doses of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE)
Time frame: 12 months
Initial pharmacokinetic and pharmacodynamic profiles of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE)
Time frame: 12 months
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Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Metroplex Clinical Research Center
Dallas, Texas, United States