search
Back to results

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

Primary Purpose

Healthy Subjects

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
PRS-060
Placebo
Sponsored by
Pieris Australia Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Subjects focused on measuring Asthma, Anticalin, PRS-060, Healthy Volunteers, Pieris, IL-4 receptor alpha, IL-13, IL-4

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Nucleus Network Limited

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

PRS-060

Arm Description

Outcomes

Primary Outcome Measures

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.
Change in blood pressure.
To assess blood pressure (systolic and diastolic) as a criterion of safety and tolerability variables.
Change in heart rate.
To assess changes in beats per minute (BPM) as a criterion of safety and tolerability variables.
Change in body temperature.
To assess changes in body temperature as a criterion of safety and tolerability variables as measure in degrees Celsius.
Change in electrocardiograms (ECGs).
To assess changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables.
Change in FEV1 (Forced expiratory volume 1-second)
To assess changes in FEV1 (Forced expiratory volume 1-second) as measured in L.
Change in FEV6 (Forced expiratory volume 6-seconds)
To assess changes in FEV6 (Forced expiratory volume 6-seconds) as measured in L.
Change in peak expiratory flow rate (PEFR)
To assess changes in PEFR (Peak expiratory flow rate) as measured in L/s.
Change in forced vital capacity (FVC)
To assess changes in FVC (Forced vital capacity) as measured by a percentage (%) predicted.
Change in sodium levels as part of standard serum chemistry panel.
To assess changes in sodium levels as measured in mmol/L.
Change in potassium levels as part of standard serum chemistry panel.
To assess changes in potassium levels as measured in mmol/L.
Change in chloride levels as part of standard serum chemistry panel.
To assess changes in chloride levels as measured in mmol/L.
Change in bicarbonate levels as part of standard serum chemistry panel.
To assess changes in bicarbonate levels as measured in mmol/L.
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.
Change in creatinine levels as part of standard serum chemistry panel.
To assess changes in creatinine levels as measured in umol/L.
Change in total protein levels as part of standard serum chemistry panel.
To assess changes in total protein levels as measured in g/L.
Changes in total albumin levels as part of standard serum chemistry panel.
To assess changes in total albumin levels as measured in g/L.
Change in total ALP levels as part of standard serum chemistry panel.
To assess changes in ALP levels as measured in U/L.
Change in total ALT levels as part of standard serum chemistry panel.
To assess changes in total ALT levels as measured in U/L.
Change in total AST levels as part of standard serum chemistry panel.
To assess changes in total AST levels as measured in U/L.
Change in total bilirubin levels as part of standard serum chemistry panel.
To assess changes in total bilirubin levels as measured in umol/L.
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.
Change in total amylase levels as part of standard serum chemistry panel.
To assess changes in total amylase levels as measured in U/L.
Change in total lipase levels as part of standard serum chemistry panel.
To assess changes in total lipase levels as measured in U/L.
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.
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.
Change in total calcium levels as part of standard serum chemistry panel.
To assess changes in total calcium levels as measured in mmol/L.
Change in total magnesium levels as part of standard serum chemistry panel.
To assess changes in total magnesium levels as measured in mmol/L.
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.
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.
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.
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.
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.
Change in hematocrit as part of standard hematology panel.
To assess changes in total hematocrit levels as measured by %.
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.
Change in platelet (PLT) counts as part of standard hematology panel.
To assess changes in platelet counts as measured by 10^9/uL.
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.
Change in neutrophil percentage as part of standard hematology panel.
To assess changes in neutrophil percentage as measured by %.
Change in lymphocyte percentage as part of standard hematology panel.
To assess changes in lymphocyte percentage as measured by %.
Change in eosinophil percentage as part of standard hematology panel.
To assess changes in eosinophil percentage as measured by %.
Change in basophil percentage as part of standard hematology panel.
To assess changes in basophil percentage as measured by %.
Change in monocyte percentage as part of standard hematology panel.
To assess changes in monocyte percentage as measured by %.
Change in clarity as part of a standard urinalysis panel.
To assess changes in clarity of the urine sample.
Change in specific gravity as part of a standard urinalysis panel.
To assess changes in specific gravity of the urine sample.
Change in pH as part of a standard urinalysis panel.
To assess changes in pH of the urine sample.
Change in protein levels as part of a standard urinalysis panel.
To assess changes in protein levels of the urine sample.
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.
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.
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.
Change in nitrite levels as part of a standard urinalysis panel.
To assess changes in nitrite levels of the urine sample.
Change in leukocyte esterase levels as part of a standard urinalysis panel.
To assess changes in leukocyte esterase levels of the urine sample.

Secondary Outcome Measures

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
PK assessment Tmax (Time to reach 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
PK assessment: t1/2 (Terminal half-life)
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
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
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
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
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
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
PK assessment of urine
Evaluation of PRS-060 levels in the urine after a single inhaled or IV infusion dose of PRS-060

Full Information

First Posted
November 26, 2017
Last Updated
November 13, 2020
Sponsor
Pieris Australia Pty Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT03384290
Brief Title
Study of a Single Dose of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 8, 2017 (Actual)
Primary Completion Date
October 11, 2018 (Actual)
Study Completion Date
October 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pieris Australia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects
Keywords
Asthma, Anticalin, PRS-060, Healthy Volunteers, Pieris, IL-4 receptor alpha, IL-13, IL-4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
Randomization is assigned by the pharmacist according to predetermined randomization code.
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
PRS-060
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PRS-060
Intervention Description
Drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
PRS-060 Matching Placebo
Primary Outcome Measure Information:
Title
Number of participants with Adverse Events (AEs) after a single inhaled or IV infusion dose of PRS-060.
Description
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.
Time Frame
From time of dose until 30 days after dosing.
Title
Change in blood pressure.
Description
To assess blood pressure (systolic and diastolic) as a criterion of safety and tolerability variables.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in heart rate.
Description
To assess changes in beats per minute (BPM) as a criterion of safety and tolerability variables.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in body temperature.
Description
To assess changes in body temperature as a criterion of safety and tolerability variables as measure in degrees Celsius.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in electrocardiograms (ECGs).
Description
To assess changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in FEV1 (Forced expiratory volume 1-second)
Description
To assess changes in FEV1 (Forced expiratory volume 1-second) as measured in L.
Time Frame
Pre-dose and post-dose at 5,10, 20 minutes,1 and 4 hours
Title
Change in FEV6 (Forced expiratory volume 6-seconds)
Description
To assess changes in FEV6 (Forced expiratory volume 6-seconds) as measured in L.
Time Frame
Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
Title
Change in peak expiratory flow rate (PEFR)
Description
To assess changes in PEFR (Peak expiratory flow rate) as measured in L/s.
Time Frame
Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
Title
Change in forced vital capacity (FVC)
Description
To assess changes in FVC (Forced vital capacity) as measured by a percentage (%) predicted.
Time Frame
Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
Title
Change in sodium levels as part of standard serum chemistry panel.
Description
To assess changes in sodium levels as measured in mmol/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in potassium levels as part of standard serum chemistry panel.
Description
To assess changes in potassium levels as measured in mmol/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in chloride levels as part of standard serum chemistry panel.
Description
To assess changes in chloride levels as measured in mmol/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in bicarbonate levels as part of standard serum chemistry panel.
Description
To assess changes in bicarbonate levels as measured in mmol/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in blood urea nitrogen (BUN) / Urea levels as part of standard serum chemistry panel.
Description
To assess changes in BUN/Urea levels as measured in mmol/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in creatinine levels as part of standard serum chemistry panel.
Description
To assess changes in creatinine levels as measured in umol/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total protein levels as part of standard serum chemistry panel.
Description
To assess changes in total protein levels as measured in g/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Changes in total albumin levels as part of standard serum chemistry panel.
Description
To assess changes in total albumin levels as measured in g/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total ALP levels as part of standard serum chemistry panel.
Description
To assess changes in ALP levels as measured in U/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total ALT levels as part of standard serum chemistry panel.
Description
To assess changes in total ALT levels as measured in U/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total AST levels as part of standard serum chemistry panel.
Description
To assess changes in total AST levels as measured in U/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total bilirubin levels as part of standard serum chemistry panel.
Description
To assess changes in total bilirubin levels as measured in umol/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total indirect bilirubin levels as part of standard serum chemistry panel.
Description
To assess changes in total indirect bilirubin levels as measured in umol/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total amylase levels as part of standard serum chemistry panel.
Description
To assess changes in total amylase levels as measured in U/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total lipase levels as part of standard serum chemistry panel.
Description
To assess changes in total lipase levels as measured in U/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total uric acid levels as part of standard serum chemistry panel.
Description
To assess changes in total uric acid levels as measured in mmol/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total creatine kinase (CK) levels as part of standard serum chemistry panel.
Description
To assess changes in total CK levels as measured in U/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total calcium levels as part of standard serum chemistry panel.
Description
To assess changes in total calcium levels as measured in mmol/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total magnesium levels as part of standard serum chemistry panel.
Description
To assess changes in total magnesium levels as measured in mmol/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total lactate dehydrogenase (LDH) levels as part of standard serum chemistry panel.
Description
To assess changes in total LDH levels as measured in U/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total immunoglobulin (IgG) levels as part of standard serum chemistry panel.
Description
To assess changes in total IgG levels as measured in g/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total immunoglobulin (IgA) levels as part of standard serum chemistry panel.
Description
To assess changes in total IgA levels as measured in g/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Changes in total immunoglobulin (IgE) levels as part of standard serum chemistry panel.
Description
To assess changes in total IgE levels as measured in g/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in total immunoglobulin (IgM) levels as part of standard serum chemistry panel.
Description
To assess changes in total IgM levels as measured in g/L.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in hematocrit as part of standard hematology panel.
Description
To assess changes in total hematocrit levels as measured by %.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in red blood cell (RBC) counts as part of standard hematology panel.
Description
To assess changes in total red blood cell (RBC) counts as measured by 10^6/uL.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in platelet (PLT) counts as part of standard hematology panel.
Description
To assess changes in platelet counts as measured by 10^9/uL.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in white blood cell (WBC) counts as part of standard hematology panel.
Description
To assess changes in white blood cell (WBC) counts as measured by 10^3/uL.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in neutrophil percentage as part of standard hematology panel.
Description
To assess changes in neutrophil percentage as measured by %.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in lymphocyte percentage as part of standard hematology panel.
Description
To assess changes in lymphocyte percentage as measured by %.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in eosinophil percentage as part of standard hematology panel.
Description
To assess changes in eosinophil percentage as measured by %.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in basophil percentage as part of standard hematology panel.
Description
To assess changes in basophil percentage as measured by %.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in monocyte percentage as part of standard hematology panel.
Description
To assess changes in monocyte percentage as measured by %.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in clarity as part of a standard urinalysis panel.
Description
To assess changes in clarity of the urine sample.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in specific gravity as part of a standard urinalysis panel.
Description
To assess changes in specific gravity of the urine sample.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in pH as part of a standard urinalysis panel.
Description
To assess changes in pH of the urine sample.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in protein levels as part of a standard urinalysis panel.
Description
To assess changes in protein levels of the urine sample.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in glucose levels as part of a standard urinalysis panel.
Description
To assess changes in glucose levels of the urine sample as measured by a positive or negative result.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in ketone levels as part of a standard urinalysis panel.
Description
To assess changes in ketone levels of the urine sample as measured by a positive or negative result.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in blood levels as part of a standard urinalysis panel.
Description
To assess changes in blood levels of the urine sample as measured by a positive or negative result.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in nitrite levels as part of a standard urinalysis panel.
Description
To assess changes in nitrite levels of the urine sample.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Title
Change in leukocyte esterase levels as part of a standard urinalysis panel.
Description
To assess changes in leukocyte esterase levels of the urine sample.
Time Frame
Screening, day 1, day 2, day 3 and 30 days after dosing.
Secondary Outcome Measure Information:
Title
PK assessment: Cmax (observed maximum serum concentration taken directly from the individual concentration-time curve)
Description
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
Time Frame
Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
Title
PK assessment Tmax (Time to reach maximum serum concentration, taken directly from the individual concentration-time curve)
Description
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
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)
Title
PK assessment: t1/2 (Terminal half-life)
Description
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
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
Title
PK assessment: AUC(0-last) (Area under the serum concentration-curve from time zero to the time of last quantifiable analyte concentration)
Description
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
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
Title
PK assessment: AUC (Area under the concentration-time curve in the serum zero (pre-dose) extrapolated to infinite time)
Description
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
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
Title
PK assessment: AUC(0-24) (Area under the plasma concentration-curve)
Description
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
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
Title
PK assessment: Vz/F (Apparent volume of distribution during terminal phase)
Description
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
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
Title
PK assessment: CL/F (Apparent oral clearance estimated as dose divided by AUC)
Description
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
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
Title
PK assessment of urine
Description
Evaluation of PRS-060 levels in the urine after a single inhaled or IV infusion dose of PRS-060
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Lickliter, MBBS PhD
Organizational Affiliation
Nucleus Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nucleus Network Limited
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs