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A Study to Assess the Safety and Tolerability of Multiple Doses of Multi-Level of a Drug in Subjects With Moderate Asthma

Asthma Clinical Trial

Official title:
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

Clinical Trial Summary

This study includes subjects with asthma to participate in one of three groups and randomly assigned to a group to receive the drug for the study (CAT-354) or placebo.

Clinical Trial Description

This study is a randomised, 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00974675
Study type Interventional
Source MedImmune LLC
Contact
Status Completed
Phase Phase 1
Start date September 2006
Completion date October 2007
View Details
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