NCT01127321

A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus

A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).

Detailed description

This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of escalating single subcutaneous doses of MEDI-570 in adult subjects with moderately to severely active SLE.

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
OTHER	Placebo	A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
BIOLOGICAL	MEDI-570 0.03 MG	A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
BIOLOGICAL	MEDI-570 0.1 MG	A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
BIOLOGICAL	MEDI-570 0.3 MG	A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
BIOLOGICAL	MEDI-570 1 MG	A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-05-20
• Last updated: 2014-08-26
• Results posted: 2014-08-26

Locations

17 sites across 5 countries: United States, Canada, Mexico, Peru, South Africa