This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma.
This study (MI-CP138) is a Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma. Approximately three investigative sites in Canada will participate in this study, with up to 40 evaluable patients randomized in a 1:1 ratio to receive MEDI-528 (9.0 mg/kg) or placebo as a single IV infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion
Placebo administered as a single intravenous infusion
McMaster University
Hamilton, Ontario, Canada
Hopital Laval
Québec, Quebec, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7
Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge.
Time frame: Day 7
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28
Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Time frame: Day 28
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56
Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Time frame: Day 56
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7
Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Time frame: Day 7
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28
Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Time frame: Day 28
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56
Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Time frame: Day 56
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Incidence of Adverse Events
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Time frame: Days 0 - 126
Incidence of Serious Adverse Events
Number of participants experiencing serious adverse events
Time frame: Days 0 - 126
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Number of participants with ADA to MEDI-528
Time frame: Days 0, 27, 55, 84, and 126
Time to Observed Maximum Serum Concentration (Tmax)
Tmax of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Time to Observed Maximum Sputum Concentration (Tmax)
Tmax of MEDI-528 in sputum
Time frame: Days -21 to -7, 7, 28, and 56
Time to Observed Maximum Nasal Lavage Concentration (Tmax)
Tmax of MEDI-528 in nasal lavage
Time frame: Days -6 to -1, 8, 29, and 57
Observed Maximum Serum Concentration (Cmax)
Cmax of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Observed Maximum Sputum Concentration (Cmax)
Cmax of MEDI-528 in sputum
Time frame: Days -21 to -7, 7, 28, and 56
Observed Maximum Nasal Lavage Concentration (Cmax)
Cmax of MEDI-528 in nasal lavage
Time frame: Days -6 to -1, 8, 29, and 57
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
AUC(0-t) of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
AUC(0-t) of MEDI-528 in sputum
Time frame: Days -21 to -7, 7, 28, and 56
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
AUC(0-t) of MEDI-528 in nasal lavage
Time frame: Days -6 to -1, 8, 29, and 57
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
AUC(0-infinity) of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
AUC(0-infinity) of MEDI-528 in sputum
Time frame: Days -21 to -7, 7, 28, and 56
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
AUC(0-infinity) of MEDI-528 in nasal lavage
Time frame: Days -6 to -1, 8, 29, and 57
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
AUC(ext) of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
AUC(ext) of MEDI-528 in sputum
Time frame: Days -21 to -7, 7, 28, and 56
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
AUC(ext) of MEDI-528 in nasal lavage
Time frame: Days -6 to -1, 8, 29, and 57
Terminal Phase Half-Life (T1/2)
T1/2 of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Terminal Phase Half-Life (T1/2)
T1/2 of MEDI-528 in sputum
Time frame: Days -21 to -7, 7, 28, and 56
Terminal Phase Half-Life (T1/2)
T1/2 of MEDI-528 in nasal lavage
Time frame: Days -6 to -1, 8, 29, and 57
Total Body Clearance (CL)
CL of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Terminal Phase Volume of Distribution (Vz)
Vz of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126