A Phase 1a, randomized, placebo controlled, two-way crossover study is to determine the effect of inhaled MMI-0100 compared to placebo following LPS challenge on inflammatory markers.
The purpose of this Phase 1a, randomized, placebo controlled, two-way crossover study is to determine the effect of inhaled MMI-0100 compared to placebo on inflammatory markers following 5 days once daily (qd) dose of MMI-0100 or placebo administered by inhalation. On Day 5 of each treatment period, subjects will be challenged with inhaled LPS. Pharmacokinetics and biomarkers will be conducted at selected timepoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Respiratory Clinical Trials, The Heart Lung Centre
London, England, United Kingdom
Adverse Events
Time frame: 6 weeks
Cytokine Biomarkers
Time frame: 6 weeks
Neutrophil cell counts in sputum following LPS challenge
Time frame: Within 1 day following challenge
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