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Completed

NCT Number: NCT03384290

Study of a Single Dose of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects

A Dose Escalating Study of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects

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Key information

Conditions

Healthy Subjects Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Limited

Melbourne, Victoria, 3004, Australia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female of non-childbearing potential (post-menopausal or surgically sterilized) subjects of 18 to 55 years of age
  • Body mass index (BMI) of 18-35
  • Subjects who are non-smokers or ex-smokers who have not smoked in the last 6 months (determined by urine cotinine < 500 ng/ml, at screening visit).

Exclusion criteria

  • History or clinical manifestations of any clinically significant medical disorder that, in the opinion of the investigator, may put the subject at risk because of participation in the study, influence the results of the study or affect the subject's ability to participate in the study.
  • A history of drug or alcohol abuse.
  • History of, or known significant infection including hepatitis A, B, or C, Human immunodeficiency Virus (HIV), tuberculosis (i.e., positive result for Interferon (INF)-y release assay (IGRA), QuantiFERON TB-Gold), that may put the subject at risk during participation in the study.
  • Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of day 1 or planned inpatient surgery or hospitalization during the study period.
  • Subjects with any history of malignancy or neoplastic disease.
  • Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the principal investigator.
  • Subjects who have received live or attenuated vaccine in the 4 weeks prior to day 1 subjects with a disease history suggesting abnormal immune function
  • Inability to communicate well with the Investigator (i.e. language problem, poor mental development or impaired cerebral function)
  • Participation in any clinical study for a New Chemical Entity within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks or within 5 half- lives, whichever is the longer, before the first dose of study drug.
  • Donation of 450 ml or more blood within the previous 12 weeks
  • Women who are pregnant
  • Males who are sexually active with a female partner of childbearing potential and who have not had a vasectomy and who do not agree to double methods of contraception with at least one barrier from day 1 for 90 days.

Treatment and study plan

PRS-060

Drug

Drug

Placebo

Drug

PRS-060 Matching Placebo

Primary outcomes

  1. Number of participants with Adverse Events (AEs) after a single inhaled or IV infusion dose of PRS-060.

    Time frame: From time of dose until 30 days after dosing.

    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.

  2. Change in blood pressure.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess blood pressure (systolic and diastolic) as a criterion of safety and tolerability variables.

  3. Change in heart rate.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in beats per minute (BPM) as a criterion of safety and tolerability variables.

  4. Change in body temperature.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in body temperature as a criterion of safety and tolerability variables as measure in degrees Celsius.

  5. Change in electrocardiograms (ECGs).

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables.

  6. Change in FEV1 (Forced expiratory volume 1-second)

    Time frame: Pre-dose and post-dose at 5,10, 20 minutes,1 and 4 hours

    To assess changes in FEV1 (Forced expiratory volume 1-second) as measured in L.

  7. Change in FEV6 (Forced expiratory volume 6-seconds)

    Time frame: Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours

    To assess changes in FEV6 (Forced expiratory volume 6-seconds) as measured in L.

  8. Change in peak expiratory flow rate (PEFR)

    Time frame: Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours

    To assess changes in PEFR (Peak expiratory flow rate) as measured in L/s.

  9. Change in forced vital capacity (FVC)

    Time frame: Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours

    To assess changes in FVC (Forced vital capacity) as measured by a percentage (%) predicted.

  10. Change in sodium levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in sodium levels as measured in mmol/L.

  11. Change in potassium levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in potassium levels as measured in mmol/L.

  12. Change in chloride levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in chloride levels as measured in mmol/L.

  13. Change in bicarbonate levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in bicarbonate levels as measured in mmol/L.

  14. Change in blood urea nitrogen (BUN) / Urea levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in BUN/Urea levels as measured in mmol/L.

  15. Change in creatinine levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in creatinine levels as measured in umol/L.

  16. Change in total protein levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total protein levels as measured in g/L.

  17. Changes in total albumin levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total albumin levels as measured in g/L.

  18. Change in total ALP levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in ALP levels as measured in U/L.

  19. Change in total ALT levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total ALT levels as measured in U/L.

  20. Change in total AST levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total AST levels as measured in U/L.

  21. Change in total bilirubin levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total bilirubin levels as measured in umol/L.

  22. Change in total indirect bilirubin levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total indirect bilirubin levels as measured in umol/L.

  23. Change in total amylase levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total amylase levels as measured in U/L.

  24. Change in total lipase levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total lipase levels as measured in U/L.

  25. Change in total uric acid levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total uric acid levels as measured in mmol/L.

  26. Change in total creatine kinase (CK) levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total CK levels as measured in U/L.

  27. Change in total calcium levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total calcium levels as measured in mmol/L.

  28. Change in total magnesium levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total magnesium levels as measured in mmol/L.

  29. Change in total lactate dehydrogenase (LDH) levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total LDH levels as measured in U/L.

  30. Change in total immunoglobulin (IgG) levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total IgG levels as measured in g/L.

  31. Change in total immunoglobulin (IgA) levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total IgA levels as measured in g/L.

  32. Changes in total immunoglobulin (IgE) levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total IgE levels as measured in g/L.

  33. Change in total immunoglobulin (IgM) levels as part of standard serum chemistry panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total IgM levels as measured in g/L.

  34. Change in hematocrit as part of standard hematology panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total hematocrit levels as measured by %.

  35. Change in red blood cell (RBC) counts as part of standard hematology panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in total red blood cell (RBC) counts as measured by 10^6/uL.

  36. Change in platelet (PLT) counts as part of standard hematology panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in platelet counts as measured by 10^9/uL.

  37. Change in white blood cell (WBC) counts as part of standard hematology panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in white blood cell (WBC) counts as measured by 10^3/uL.

  38. Change in neutrophil percentage as part of standard hematology panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in neutrophil percentage as measured by %.

  39. Change in lymphocyte percentage as part of standard hematology panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in lymphocyte percentage as measured by %.

  40. Change in eosinophil percentage as part of standard hematology panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in eosinophil percentage as measured by %.

  41. Change in basophil percentage as part of standard hematology panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in basophil percentage as measured by %.

  42. Change in monocyte percentage as part of standard hematology panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in monocyte percentage as measured by %.

  43. Change in clarity as part of a standard urinalysis panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in clarity of the urine sample.

  44. Change in specific gravity as part of a standard urinalysis panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in specific gravity of the urine sample.

  45. Change in pH as part of a standard urinalysis panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in pH of the urine sample.

  46. Change in protein levels as part of a standard urinalysis panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in protein levels of the urine sample.

  47. Change in glucose levels as part of a standard urinalysis panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in glucose levels of the urine sample as measured by a positive or negative result.

  48. Change in ketone levels as part of a standard urinalysis panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in ketone levels of the urine sample as measured by a positive or negative result.

  49. Change in blood levels as part of a standard urinalysis panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in blood levels of the urine sample as measured by a positive or negative result.

  50. Change in nitrite levels as part of a standard urinalysis panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in nitrite levels of the urine sample.

  51. Change in leukocyte esterase levels as part of a standard urinalysis panel.

    Time frame: Screening, day 1, day 2, day 3 and 30 days after dosing.

    To assess changes in leukocyte esterase levels of the urine sample.

Secondary outcomes

  1. PK assessment: Cmax (observed maximum serum concentration taken directly from the individual concentration-time curve)

    Time frame: Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours

    Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060

  2. PK assessment Tmax (Time to reach maximum serum concentration, taken directly from the individual concentration-time curve)

    Time frame: 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)

    Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060

  3. PK assessment: t1/2 (Terminal half-life)

    Time frame: 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

    Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060

  4. PK assessment: AUC(0-last) (Area under the serum concentration-curve from time zero to the time of last quantifiable analyte concentration)

    Time frame: 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

    Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060

  5. PK assessment: AUC (Area under the concentration-time curve in the serum zero (pre-dose) extrapolated to infinite time)

    Time frame: 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

    Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060

  6. PK assessment: AUC(0-24) (Area under the plasma concentration-curve)

    Time frame: 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

    Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060

  7. PK assessment: Vz/F (Apparent volume of distribution during terminal phase)

    Time frame: 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

    Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060

  8. PK assessment: CL/F (Apparent oral clearance estimated as dose divided by AUC)

    Time frame: 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

    Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060

  9. PK assessment of urine

    Time frame: 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

    Evaluation of PRS-060 levels in the urine after a single inhaled or IV infusion dose of PRS-060

Sponsors and collaborators

Lead sponsor

Pieris Australia Pty Ltd

Industry

Registry information

Official study title

A Dose Escalating Single Blind Study to Assess the Safety, Tolerability and Pharmacokinetics of a Single Dose of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 27, 2017
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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