The purpose of this study is to examine the effects of multi-dose regimens of IPI-145 on lung function in mild asthmatic subjects following allergen challenge.
This is a phase 2a, randomized, double-blind, placebo-controlled, multi-dose, 2-way cross-over study designed to examine the effect of IPI-145 on lung function and inflammatory indices in mild, allergen-reactive asthmatic subjects undergoing allergen challenge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Active drug
Comparator
Investigational Site
Berlin, Germany
Investigational Site
Großhansdorf, Germany
Investigational Site
Wiesbaden, Germany
Investigational Site
Harrow, United Kingdom
Forced Expiratory Volume in one second (FEV1)
Time frame: Day 14
Maximum concentration (Cmax), Area Under the Curve, and terminal elimination half-life (T1/2) pre-dose and up to 12 hours post dose
Time frame: Day 14
Number of Participants with Adverse Events as a Measure of Safety
Time frame: From signing of informed consent through 21 days following study drug administration
Change in C-reactive Protein (CRP) levels
Time frame: Screening and/or Day 1 of each treatment period
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