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A Dose Escalating Study of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects
PRS-060 is a new drug being developed for treatment of asthma. The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single ascending doses of PRS-060 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| PRS-060 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRS-060 | Drug | Drug |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) after a single inhaled or IV infusion dose of PRS-060. | The number of participants with treatment related AEs as assessed by CTCAE v4.0. Subjects will be monitored for AEs during study participation (beginning at the time study drug is first administered) until 30 days after dosing. | From time of dose until 30 days after dosing. |
| Change in blood pressure. | To assess blood pressure (systolic and diastolic) as a criterion of safety and tolerability variables. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in heart rate. | To assess changes in beats per minute (BPM) as a criterion of safety and tolerability variables. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in body temperature. | To assess changes in body temperature as a criterion of safety and tolerability variables as measure in degrees Celsius. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in electrocardiograms (ECGs). | To assess changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in FEV1 (Forced expiratory volume 1-second) | To assess changes in FEV1 (Forced expiratory volume 1-second) as measured in L. | Pre-dose and post-dose at 5,10, 20 minutes,1 and 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| PK assessment: Cmax (observed maximum serum concentration taken directly from the individual concentration-time curve) | Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060 | Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours |
| PK assessment Tmax (Time to reach maximum serum concentration, taken directly from the individual concentration-time curve) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Lickliter, MBBS PhD | Nucleus Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Limited | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Single Group Assignment This is a phase 1, dose escalating study to assess safety, tolerability, and PK of a single dose of PRS-060 administered by oral inhalation or IV infusion to healthy male and female subjects. This study will be conducted utilizing a single-blind, randomized, dose-escalating design.
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Randomization is assigned by the pharmacist according to predetermined randomization code.
| Drug |
PRS-060 Matching Placebo |
|
| Change in FEV6 (Forced expiratory volume 6-seconds) | To assess changes in FEV6 (Forced expiratory volume 6-seconds) as measured in L. | Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours |
| Change in peak expiratory flow rate (PEFR) | To assess changes in PEFR (Peak expiratory flow rate) as measured in L/s. | Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours |
| Change in forced vital capacity (FVC) | To assess changes in FVC (Forced vital capacity) as measured by a percentage (%) predicted. | Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours |
| Change in sodium levels as part of standard serum chemistry panel. | To assess changes in sodium levels as measured in mmol/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in potassium levels as part of standard serum chemistry panel. | To assess changes in potassium levels as measured in mmol/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in chloride levels as part of standard serum chemistry panel. | To assess changes in chloride levels as measured in mmol/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in bicarbonate levels as part of standard serum chemistry panel. | To assess changes in bicarbonate levels as measured in mmol/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in blood urea nitrogen (BUN) / Urea levels as part of standard serum chemistry panel. | To assess changes in BUN/Urea levels as measured in mmol/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in creatinine levels as part of standard serum chemistry panel. | To assess changes in creatinine levels as measured in umol/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| 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, day 1, day 2, day 3 and 30 days after dosing. |
| Changes in total albumin levels as part of standard serum chemistry panel. | To assess changes in total albumin levels as measured in g/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in total ALP levels as part of standard serum chemistry panel. | To assess changes in ALP levels as measured in U/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in total ALT levels as part of standard serum chemistry panel. | To assess changes in total ALT levels as measured in U/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in total AST levels as part of standard serum chemistry panel. | To assess changes in total AST levels as measured in U/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| 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, day 1, day 2, day 3 and 30 days after dosing. |
| Change in total indirect bilirubin levels as part of standard serum chemistry panel. | To assess changes in total indirect bilirubin levels as measured in umol/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in total amylase levels as part of standard serum chemistry panel. | To assess changes in total amylase levels as measured in U/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in total lipase levels as part of standard serum chemistry panel. | To assess changes in total lipase levels as measured in U/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in total uric acid levels as part of standard serum chemistry panel. | To assess changes in total uric acid levels as measured in mmol/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in total creatine kinase (CK) levels as part of standard serum chemistry panel. | To assess changes in total CK levels as measured in U/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in total calcium levels as part of standard serum chemistry panel. | To assess changes in total calcium levels as measured in mmol/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in total magnesium levels as part of standard serum chemistry panel. | To assess changes in total magnesium levels as measured in mmol/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in total lactate dehydrogenase (LDH) levels as part of standard serum chemistry panel. | To assess changes in total LDH levels as measured in U/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| 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, day 1, day 2, day 3 and 30 days after dosing. |
| Change 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, day 1, day 2, day 3 and 30 days after dosing. |
| Changes in total immunoglobulin (IgE) levels as part of standard serum chemistry panel. | To assess changes in total IgE levels as measured in g/L. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| 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, day 1, day 2, day 3 and 30 days after dosing. |
| Change in hematocrit as part of standard hematology panel. | To assess changes in total hematocrit levels as measured by %. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in red blood cell (RBC) counts as part of standard hematology panel. | To assess changes in total red blood cell (RBC) counts as measured by 10^6/uL. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in platelet (PLT) counts as part of standard hematology panel. | To assess changes in platelet counts as measured by 10^9/uL. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in white blood cell (WBC) counts as part of standard hematology panel. | To assess changes in white blood cell (WBC) counts as measured by 10^3/uL. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in neutrophil percentage as part of standard hematology panel. | To assess changes in neutrophil percentage as measured by %. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in lymphocyte percentage as part of standard hematology panel. | To assess changes in lymphocyte percentage as measured by %. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in eosinophil percentage as part of standard hematology panel. | To assess changes in eosinophil percentage as measured by %. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in basophil percentage as part of standard hematology panel. | To assess changes in basophil percentage as measured by %. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in monocyte percentage as part of standard hematology panel. | To assess changes in monocyte percentage as measured by %. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in clarity as part of a standard urinalysis panel. | To assess changes in clarity of the urine sample. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in specific gravity as part of a standard urinalysis panel. | To assess changes in specific gravity of the urine sample. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in pH as part of a standard urinalysis panel. | To assess changes in pH of the urine sample. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in protein levels as part of a standard urinalysis panel. | To assess changes in protein levels of the urine sample. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| 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, day 1, day 2, day 3 and 30 days after dosing. |
| 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, day 1, day 2, day 3 and 30 days after dosing. |
| 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, day 1, day 2, day 3 and 30 days after dosing. |
| Change in nitrite levels as part of a standard urinalysis panel. | To assess changes in nitrite levels of the urine sample. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
| Change in leukocyte esterase levels as part of a standard urinalysis panel. | To assess changes in leukocyte esterase levels of the urine sample. | Screening, day 1, day 2, day 3 and 30 days after dosing. |
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060 |
| Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days) |
| PK assessment: t1/2 (Terminal half-life) | Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060 | Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days |
| 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 of a single inhaled or IV infusion dose of PRS-060 | Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days |
| PK assessment: AUC (Area under the concentration-time curve in the serum zero (pre-dose) extrapolated to infinite time) | Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060 | Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days |
| PK assessment: AUC(0-24) (Area under the plasma concentration-curve) | Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060 | Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days |
| PK assessment: Vz/F (Apparent volume of distribution during terminal phase) | Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060 | Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days |
| PK assessment: CL/F (Apparent oral clearance estimated as dose divided by AUC) | Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060 | Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days |
| PK assessment of urine | Evaluation of PRS-060 levels in the urine after a single inhaled or IV infusion dose of PRS-060 | Pre-dose and continuously during the following time-intervals: 0-4, 4-8, 8-12, 12-18, 18-24, 24-30, 30-36, 36-42 and 42-48 hours |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |