A Study to Assess the Safety and Tolerability of Multiple Doses of Multi-Level of a Drug in Subjects With Moderate Asthma
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Pharmacokinetics Assessment: Individual serum concentration profiles for CAT-354 will be generated for each subject. [ Time Frame: Day 162 ] [ Designated as safety issue: Yes ]
- Safety and Tolerability Analysis based on safety population. (e.g., vital signs, lung function, ECG results, haematology, chemistry and normal ranges) [ Time Frame: Day 162 ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2006|
|Study Completion Date:||October 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
1, 5 and 10 mg/kg - Day 0,28, and 56
1,5, and 10 kg - Day 0, 28, and 56
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).