Study identifier:MI-CP143
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Effect on Exercise Challenge Testing of Multiple Fixed Subcutaneous Doses of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody, in Adults with Stable Asthma and Exercise-Induced Bronchoconstriction
asthma
Phase 2
No
-
All
11
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2014 by MedImmune
MedImmune
-
The main objective of this study is to evaluate the safety and tolerability of multiple fixed doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).
The primary objective of this study is to evaluate the safety and tolerability of multiple fixed escalating SC doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).
Location
Location
Normal, IL, United States, 61761
Location
No. Dartmouth, MA, United States, 02747
Location
Cincinnati, OH, United States, 45231
Location
Omaha, NE, United States, 68131
Location
Quebec City, Quebec, Canada, G1V4M6
Location
Waterbury, CT, United States, 06708
Location
Denver, CO, United States, 80206
Location
St. Louis, MO, United States, 63141
Arms | Assigned Interventions |
---|---|
Experimental: MEDI528 50 mg MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks | Biological/Vaccine: MEDI528 50 mg MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks |
Placebo Comparator: PLACEBO Placebo administered as a subcutaneous injection twice weekly for 4 weeks | Other: PLACEBO Placebo administered as a subcutaneous injection twice weekly for 4 weeks |
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