NCT00974675

A Study to Assess Pharmacokinetics, Safety and Tolerability of Multiple Doses of CAT-354 in Subjects With Moderate Asthma

A Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Multiple Intravenous Doses of 3 Dose Levels of CAT-354 in Subjects With Moderate Asthma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The study includes participants with moderate asthma who were randomly assigned to receive the study medication (CAT-354) or placebo.

Detailed description

This study is a randomized, double-blind, placebo controlled study. Following confirmation of eligibility, subjects with moderate asthma will be recruited sequentially to one of three dose groups and randomly assigned within dose group to either CAT-354 or placebo. Doses of the assigned treatment will be administered on three occasions 28 days apart. Follow up for pharmacokinetic blood sampling and safety will continue to Day 147 post-first dose (91 days post-third dose).

Conditions

• Moderate Asthma

Interventions

Type	Name	Description
BIOLOGICAL	CAT-354 1mg/kg	CAT-354 1 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
BIOLOGICAL	CAT-354 5 mg/kg	CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
BIOLOGICAL	CAT-354 10mg/kg	CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
OTHER	Placebo	Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.

Timeline

• Start date: 2006-09-29
• Primary completion: 2007-08-03
• Completion: 2007-08-03
• First posted: 2009-09-10
• Last updated: 2017-05-02
• Results posted: 2017-05-02

Locations

1 site across 1 country: United Kingdom