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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

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