During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.
The early and late asthmatic response were both significantly attenuated by the highest dose of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and B-Chain of IL-3-Il-5 and GMCSF were attenuated by ASM8.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
McMaster University
Hamilton, Ontario, Canada
Sputum eosinophils (%) on Day 4 versus Screening for each dose level.
Time frame: 7 and 24 hrs post-allergen challenge
Safety and tolerability.
Time frame: Throughout the study
Plasma and sputum pharmacokinetic profile at the two highest dose levels.
Time frame: Dose level 3 and 4
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4 mg/mL, 8 mg OD for 4 days