The purpose of this study is to determine the range of single inhaled doses of a new dry powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Inhaled doses of MDT-637 over a 24 hour period
West Coast Clinical Trials
Cypress, California, United States
Safety and Tolerability of 6 escalating doses of MDT-637 dry powder inhalation in healthy volunteers
Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events.
Time frame: Up to 22 days (including 14 day screening period)
Plasma pharmacokinetics for MDT-637 dry powder inhalation
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Cmax
Time frame: Multiple plasma samples collected up to 24 hours post first dose
Trough MDT-637 Nasal Concentration
Determination of MDT-637 concentration following nasal wash
Time frame: 24 hours
Plasma pharmacokinetics for MDT-637 dry powder inhalation
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Tmax
Time frame: 24 hours
Plasma pharmacokinetics of MDT-637 dry powder inhalation
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by AUC
Time frame: 24 hours
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