The purpose of this study is to assess the safety and tolerability of PUR0200. In addition, the study will look at the blood levels of different doses of PUR0200 and their affect on lung function in COPD patients.
This is a multi-center, 2-part, pharmacokinetic (PK), pharmacodynamic (PD) effect, safety and tolerability study of single doses of PUR0200.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator
Randomized, single dose of inhaled placebo matched to PUR0200
Randomized single dose of inhaled active comparator product
Medicines Evaluation Unit
Manchester, United Kingdom
Quotient Clinical
Nottingham, United Kingdom
Peak plasma concentration (Cmax) of PUR0200
Time frame: 0 to 24 hours
Time to reach peak plasma (Tmax) concentration of PUR0200
Time frame: 0 to 24 hours
Area under the plasma concentration versus time (AUC) of PUR0200
Time frame: 0 to 24 hours
Trough forced expiratory volume in 1 second (FEV1)
Time frame: 24 hours
Trough FEV1 difference from baseline
Time frame: 24 hours
Number of participants with adverse events
adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated
Time frame: up to 14 days post-dose
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