A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)

Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)

To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.

This is a phase 1, randomized, double-blind, placebo-controlled, single-and multiple ascending dose study. Up to eighty-eight subjects with Systemic Lupus Erythematosus will be selected to participate. Subjects will be randomized to receive either ABT-199 or placebo. Subjects will be administered ABT-199/placebo as a single dose or up to 14 days as multiple doses.

Inclusion Criteria:

• Diagnosis of systemic lupus erythematosus for at least 6 months.
• Documentation of at least one of the following: ANA titer >= 1:160 or positive anti-dsDNA antibodies.
• Stable systemic lupus erythematosus medication regimen.
• Other than systemic lupus erythematosus, subject should be in general good health.

Exclusion Criteria:

• Male.
• Drug-induced or highly active systemic lupus erythematosus.
• Significant autoimmune disease other than lupus.
• Significant, uncontrolled or unstable disease in any organ.