The study includes participants with moderate asthma who were randomly assigned to receive the study medication (CAT-354) or placebo.
This study is a randomized, 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
CAT-354 1 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
Chiltern International Limited
Slough, Berkshire, United Kingdom
Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35
Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose
Terminal elimination phase half-life is the time measured for the serum concentration to decrease by one half.
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Clearance (CL) for CAT-354 After First Dose
Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance was normalized by the body weight of the participant.
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Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Volume of Distribution (Vd) for CAT-354 After First Dose
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution was normalized to the body weight of the participant.
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose
Time frame: Pre-dose on Day 28
Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose
Time frame: Pre-dose on Day 56
Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose
Time frame: Day 84
Accumulation Ratio (R0) for CAT-354
Accumulation ratio is calculated as: R0 = AUC(56 - 84)/AUC(0 - 28) where AUC(0 - 28) and AUC(56 - 84) are the area under the serum concentration time curve over a dosage interval determined after the first dose (Day 0 to Day 28) and after the third dose (Day 56 to Day 84), respectively.
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 147 that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: Day 0 to Day 147