Lupus Erythematosus, Systemic
Conditions
Keywords
safety, pharmacokinetics
Brief summary
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).
Interventions
DRUGSBI-087
Single IV or SC dose of SBI-087
Sponsors
Emergent Product Development Seattle LLC
Pfizer
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of SLE (by greater than or equal to 4 American College of Rheumatology \[ACR\] Revised Criteria) greater than 6 months before study day 1. * History of a positive antinuclear antibody (ANA) titer greater than or equal to 1:160 or equivalent.
Exclusion criteria
* Treatment with more than 20 mg of prednisone per day. * Evidence of unstable clinically significant disease (e.g., cardiovascular, cerebrovascular, respiratory, or renal disease, or any other unstable serious disorder) other than SLE. * History of cancer (other than resected cutaneous basal and squamous cell carcinoma or in situ cervical cancer) with less than 5 years' documentation of a disease-free state.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Initial pharmacokinetic and pharmacodynamic profiles of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE) | 12 months |
Countries
United States
Outcome results
None listed