A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts

Inclusion Criteria:

• Diagnosis of SLE with positive ANA
• Stable disease with no change in SLE therapy within the previous 30 days
• BMI from 18 to 38 kg/m2

Exclusion Criteria:

• Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization
• Evidence of renal disease or liver disease
• Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis
• Prior administration of any other biologic that primarily targets the immune system