NCT00507130

A Study to Evaluate the Safety and Tolerability of the Administration of MEDI-528 When Administered in Multiple Doses to Adults With Mild Persistent Asthma

A Phase 2A, Randomized, Double-Blind, Placebo-Controlled,Dose-Escalation Study to Evaluate the Safety and Tolerability of Multiple-Dose Subcutaneous Administration of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody,When Administered to Adults With Mild Persistent Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of escalating multiple SC doses of MEDI-528 in adult patients with mild persistent asthma.

Detailed description

The secondary objectives of this study are to: 1. Assess the PK of MEDI-528; and 2. Assess the IM of MEDI-528 in this patient population.

Conditions

• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	MEDI528 0.3 mg/kg	MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
BIOLOGICAL	MEDI528 1 mg/kg	MEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
BIOLOGICAL	MEDI528 3 mg/kg	MEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks
OTHER	PLACEBO	Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-07-01
• Completion: 2008-09-01
• First posted: 2007-07-25
• Last updated: 2013-12-11
• Results posted: 2013-12-11

Locations

9 sites across 2 countries: United States, Canada