NCT00512486

A Sequential Dose-Escalation Study in Subjects With Mild Asthma

A Multi-Center, Open-Label, Single Administration, Sequential Dose Escalation of BIW-8405/MEDI-563 in Subjects With Mild Asthma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to investigate the safety of administration of this drug by increasing doses to male and female adult subjects with mild asthma.

Detailed description

The primary objective of this study is to investigate the safety of administration of BIW-8405/MEDI-563 in increasing doses to male and female adult subjects with mild asthma.

Conditions

• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	MEDI-563	BIW-8405/MEDI-563 administered at one of five dose levels: * 0.03 mg/kg intravenous injection * 0.1 mg/kg intravenous injection * 0.3 mg/kg intravenous injection * 1.0 mg/kg intravenous injection * 3.0 mg/kg intravenous injection Following the -3.0 mg/kg dose level, BIW-8405/MEDI-563 administered at one of two lower dose levels: 0.003 mg/kg intravenous injection 0.0003 mg/kg intravenous injection

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2007-08-07
• Last updated: 2008-11-27

Locations

3 sites across 1 country: United States