Study identifier:MI-CP197
ClinicalTrials.gov identifier:NCT00783289
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple-dose Subcutaneous Administration of MEDI-563, a Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, in Adults with Asthma
asthma
Phase 2
No
-
All
35
Interventional
18 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Dec 2019 by MedImmune, LLC
MedImmune, LLC
-
The primary objective of this study is to evaluate the safety and tolerability of escalating multiple subcutaneous (SC) doses of MEDI-563 in adult subjects with asthma.
This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-escalation, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of multiple subcutaneous doses (25, 100, or 200 milligram [mg]) of benralizumab (MEDI-563) in adult subjects with asthma.
Location
Location
Upland, PA, United States
Location
Colarado Springs, CO, United States
Location
Encinitas, CA, United States
Location
Los Angeles, CA, United States
Location
Portland, OR, United States, 97213
Location
Wheaton, MD, United States
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56. | Other: Placebo Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56. |
Experimental: Benralizumab 25 mg Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56. | Biological/Vaccine: Benralizumab 25 mg Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56. Other Name: MEDI-563 |
Experimental: Benralizumab 100 mg Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56. | Biological/Vaccine: Benralizumab 100 mg Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56. Other Name: MEDI-563 |
Experimental: Benralizumab 200 mg Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56. | Biological/Vaccine: Benralizumab 200 mg Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56. Other Name: MEDI-563 |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.