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The purpose of this study is to evaluate the safety and tolerability of the dry powder formulation of ASM-024 following single and multiple administration by inhalation of ascending doses in healthy subjects and subjects with stable moderate asthma.
Full description
This is a phase I/II, randomized, double-blind, placebo-controlled study of single ascending and multiple ascending doses of ASM-024 administered by dry powder inhalation to healthy subjects and subjects with stable moderate asthma. The goal of this study is to evaluate the safety, tolerability and pharmacokinetic profile of a new, dry powder formulation of ASM-024. The doses that will be tested in subjects with asthma will be determined based on the information collected first in healthy volunteers. In addition to standard safety and tolerability evaluations, the acute effects of the study medication on the airways will be assessed.
Enrollment
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Inclusion criteria
Healthy Volunteers:
Asthmatics:
Exclusion criteria
Healthy Volunteers:
Asthmatics:
Primary purpose
Allocation
Interventional model
Masking
55 participants in 5 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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