NCT00783289

A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults With 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-563, a Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, in Adults With Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of escalating multiple subcutaneous (SC) doses of MEDI-563 in adult subjects with asthma.

Detailed description

This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-escalation, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of multiple subcutaneous doses (25, 100, or 200 milligram \[mg\]) of benralizumab (MEDI-563) in adult subjects with asthma.

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	Placebo	Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
BIOLOGICAL	Benralizumab 25 mg	Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
BIOLOGICAL	Benralizumab 100 mg	Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
BIOLOGICAL	Benralizumab 200 mg	Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Timeline

• Start date: 2008-11-14
• Primary completion: 2009-11-17
• Completion: 2009-11-17
• First posted: 2008-10-31
• Last updated: 2019-12-27
• Results posted: 2019-12-27

Locations

6 sites across 1 country: United States