Study identifier:MI-CP166
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Effects of MEDI-563, A Humanized Anti-Interleukin-5 Receptor Alpha Monoclonal Antibody, on Airway Eosinophils in Adults with Atopic Asthma
asthma
Phase 1
Yes
MEDI-563
All
27
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Oct 2012 by MedImmune, LLC
MedImmune, LLC
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Evaluate the safety and tolerability of MEDI-563 in adults with asthma and the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies
Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma; and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma.
Location
Location
Galveston, TX, United States, 77555-0561
Location
Calgary, AB, Canada, T2N4N1
Location
Montreal, QC, Canada, H2X 2P4
Location
Hamilton, ON, Canada, L8N3Z5
Location
Quebec, QC, Canada, G1V4G5
Location
Houston, TX, United States, 77030
Location
Madison, WI, United States, 53792
Location
Denver, CO, United States, 80206
Arms | Assigned Interventions |
---|---|
Experimental: 1 MEDI-563 | Drug: MEDI-563 1.0 mg/kg IV: MEDI-563 |
Experimental: 2 MEDI-563 | Drug: MEDI-563 100 mg, 200 mg SC |
Placebo Comparator: 4 Placebo | Other: Placebo Comp. Placebo SC |
Placebo Comparator: 5 Placebo | Other: Placebo Placebo as a single IV infusion (Certain number of subjects) |
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