NCT00659659

A Study to Evaluate the Safety, Tolerability and Effects of MEDI-563 in Adults With Asthma

A Phase 1, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Effects of MEDI-563, A Humanized Anti-Interleukin-5 Receptor Alpha Monoclonal Antibody, on Airway Eosinophils in Adults With Atopic Asthma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evaluate the safety and tolerability of MEDI-563 in adults with asthma and the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies

Detailed description

Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma; and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	MEDI-563	1.0 mg/kg IV: MEDI-563
DRUG	MEDI-563	100 mg, 200 mg SC
OTHER	Placebo Comp.	Placebo SC
OTHER	Placebo	Placebo as a single IV infusion (Certain number of subjects)

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-01-01
• Completion: 2011-03-01
• First posted: 2008-04-16
• Last updated: 2012-10-10

Locations

11 sites across 2 countries: United States, Canada