Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of participants with adverse events (AEs) after an inhaled dose of PRS-060 |
The number of participants with treatment related AEs as assessed by current approved CTCAE version |
From time of dose until 30 days after dosing |
|
Primary |
Change in blood pressure |
To assess blood pressure (systolic and diastolic) as a criterion of safety and tolerability variables as measured in mm Hg) |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in heart rate |
To assess changes in beats per minute (BPM) as a criterion of safety and tolerability variables |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in body temperature |
To assess changes in body temperature in degrees Celsius as a criterion of safety and tolerability variables |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in electrocardiograms (ECGs) |
To assess changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in forced expiratory volume 1-second (FEV1) as part of spirometry |
To assess changes in FEV1 as measured in mL as part of spirometry |
Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in forced vital capacity (FVC) as part of spirometry |
To assess changes in FVC as measured by mL |
Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in peak expiratory flow rate (PEFR) as part of spirometry |
To assess changes in PEFR as measured in L/min |
Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in sodium levels as part of standard serum chemistry panel |
To asses changes in sodium levels as measured in mmol/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in potassium levels as part of standard serum chemistry panel |
To assess changes in potassium levels as measured in mmol/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in chloride levels as part of standard serum chemistry panel |
To assess changes in chloride levels as measured in mmol/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days) |
|
Primary |
Change in bicarbonate levels as part of standard serum chemistry panel |
To assess changes in bicarbonate levels as measured in mmol/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in blood urea nitrogen (BUN)/Urea levels as part of standard serum chemistry panel |
To assess changes BUN/Urea levels as measured in mmol/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in creatinine levels as part of standard serum chemistry panel |
To assess changes in creatinine levels as measured in umol/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in total protein levels as part of standard serum chemistry panel |
To assess changes in total protein levels as measured in g/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in albumin levels as part of standard serum chemistry panel |
To assess changes in albumin levels as measure in g/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in alkaline phosphate (ALP) levels as part of standard serum chemistry panel |
To assess changes in ALP levels as measured in U/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in ALT levels as part of standard serum chemistry panel |
To assess changes in ALT levels as measured in U/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Changes in AST levels as part of standard serum chemistry panel |
To assess changes in AST levels as measured in U/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in total bilirubin levels as part of standard serum chemistry panel |
To assess changes in total bilirubin levels as measured in umol/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in direct bilirubin levels as part of standard serum chemistry panel |
To assess changes in direct bilirubin levels as measured in umol/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in indirect bilirubin levels as part of standard serum chemistry panel |
To assess changes in indirect bilirubin levels as measured in umol/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in amylase levels as part of standard serum chemistry panel |
To assess changes in amylase levels as measured in U/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in lipase levels as part of standard serum chemistry panel |
To assess changes in lipase levels as measured in U/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in uric acid levels as part of standard serum chemistry panel |
To assess changes in uric acid levels as measured in mmol/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in creatine kinase (CK) levels as part of standard serum chemistry panel |
To assess changes in CK levels as measured in U/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in calcium levels as part of standard serum chemistry panel |
To assess changes in calcium levels as measured in mmol/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in magnesium levels as part of standard serum chemistry panel |
To assess changes in magnesium levels as measured in mmol/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in lactate dehydrogenase (LDH) levels as part of standard serum chemistry panel. |
To assess changes in LDH levels as measure in U/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in total immunoglobulin (IgG) levels as part of standard serum chemistry panel |
To assess changes in total IgG levels as measured in g/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Changes in total immunoglobulin (IgA) levels as part of standard serum chemistry panel |
To assess changes in total IgA levels as measured in g/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Changes in total immunoglobulin (IgE) levels as part of standard serum chemistry panel |
To assess changes in total IgE levels as measured in lU/mL |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in total immunoglobulin (IgM) levels as part of standard serum chemistry panel |
To assess changes in total IgM levels as measured in g/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in hematocrit as part of standard hematology panel |
To assess changes in total hamatocrit levels as measured by % |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in hemoglobin levels as part of standard hematology panel |
To assess changes in hemoglobin levels as measured by g/L |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in red blood cells (RBC) counts as part of standard hematology panel |
To assess changes in red blood cells (RBC) counts as measured by 10^12/uL |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in platelet (PLT) counts as part of standard hematology panel |
To assess changes in PLT counts as measured by 10^9/uL |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in white blood cells (WBC) counts as part of standard hematology panel |
To assess changes in white blood cell (WBC) counts as measured by 10^9/uL |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in neutrophil percentage as part of standard hematology panel |
To assess changes in neutrophil percentages as measured by % |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in lymphocyte percentage as part of standard hematology panel |
To assess changes in lymphocyte percentage as measured by % |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in eosinophil percentage a part of standard hematology panel |
To assess changes in eosinophil percentage as measured by % |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in basophil percentage as part of standard hematology panel |
To assess changes basophil percentages as measured by % |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in monocyte percentage as part of standard hematology panel |
To assess changes in monocyte percentage as measured by % |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in clarity as part of a standard urinalysis panel |
To assess changes in clarity of the urine sample |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in specific gravity as part of a standard urinalysis panel |
To assess changes in specific gravity of the urine sample |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in pH as part of a standard urinalysis panel |
To assess changes in pH of the urine sample |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in protein levels as part of a standard urinalysis panel |
To assess changes in protein levels of the urine sample |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in glucose levels as part of a standard urinalysis panel |
To assess changes in glucose levels of the urine sample as measured by a positive or negative result. |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in ketone levels as part of a standard urinalysis panel |
To assess changes in ketone levels of the urine sample as measured by a positive or negative result |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in blood levels as part of a standard urinalysis panel |
To assess changes in blood levels of the urine sample as measured by a positive or negative result. |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in nitrite levels as part of a standard urinalysis panel |
To assess changes in nitrite levels of the urine sample |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Primary |
Change in leukocyte esterase levels as part of a standard urinalysis panel |
To assess changes in leukocyte esterase levels of the urine sample |
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Secondary |
PK assessment: Cmax (observed maximum serum concentration taken directly from the individual concentration-time curve) |
Evaluation of the PK after receiving PRS-060 |
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Secondary |
PK assessment: Tmax (time to reach maximum serum concentration, taken directly from the individual concentration-time curve) |
Evaluation of the PK after receiving PRS-060 |
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Secondary |
PK assessment: t1/2(terminal half-life) |
Evaluation of the PK after receiving PRS-060 |
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Secondary |
PK assessment: AUC (0-last) (area under the serum concentration-curve from time zero to the time of last quantifiable analyte concentration) |
Evaluation of the PK after receiving PRS-060 |
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Secondary |
PK assessment: AUC (area under the concentration-time curve in the serum zero [pre-dose] extrapolated to infinite time) |
Evaluation of the PK after receiving PRS-060 |
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Secondary |
PK assessment: AUC (0-24) (area under the plasma concentration-curve) |
Evaluation of the PK after receiving PRS-060 |
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Secondary |
PK assessment: Vz/F (apparent volume of distribution during terminal phase) |
Evaluation of the PK after receiving PRS-060 |
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Secondary |
PK assessment: CL/F (apparent oral clearance estimated as dose divided by AUC) |
Evaluation of the PK after receiving PRS-060 |
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Secondary |
PK assessment of urine |
Evaluation of PRS-060 levels in the urine after receiving PRS-060 |
During treatment and confinement |
|
Secondary |
Serum ADA assessment using bridging Immunoassay Enhanced Chemiluminescence (ECL) method |
Evaluation of potential development of ADAs against PRS-060 |
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
|
Secondary |
FeNO assessment |
Evaluation of FeNO after receiving PRS-060 or placebo |
Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days). |
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