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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03384290




Registration number
NCT03384290
Ethics application status
Date submitted
26/11/2017
Date registered
27/12/2017
Date last updated
18/04/2019

Titles & IDs
Public title
Study of a Single Dose of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects
Scientific 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
Secondary ID [1] 0 0
PRS-060-PCS_06_17
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PRS-060
Treatment: Drugs - Placebo

Placebo Comparator: Placebo -

Experimental: PRS-060 -


Treatment: Drugs: PRS-060
Drug

Treatment: Drugs: Placebo
PRS-060 Matching Placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From time of dose until 30 days after dosing.
Primary outcome [2] 0 0
Change in blood pressure. - To assess blood pressure (systolic and diastolic) as a criterion of safety and tolerability variables.
Timepoint [2] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [3] 0 0
Change in heart rate. - To assess changes in beats per minute (BPM) as a criterion of safety and tolerability variables.
Timepoint [3] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [4] 0 0
Change in body temperature. - To assess changes in body temperature as a criterion of safety and tolerability variables as measure in degrees Celsius.
Timepoint [4] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [5] 0 0
Change in electrocardiograms (ECGs). - To assess changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables.
Timepoint [5] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [6] 0 0
Change in FEV1 (Forced expiratory volume 1-second) - To assess changes in FEV1 (Forced expiratory volume 1-second) as measured in L.
Timepoint [6] 0 0
Pre-dose and post-dose at 5,10, 20 minutes,1 and 4 hours
Primary outcome [7] 0 0
Change in FEV6 (Forced expiratory volume 6-seconds) - To assess changes in FEV6 (Forced expiratory volume 6-seconds) as measured in L.
Timepoint [7] 0 0
Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
Primary outcome [8] 0 0
Change in peak expiratory flow rate (PEFR) - To assess changes in PEFR (Peak expiratory flow rate) as measured in L/s.
Timepoint [8] 0 0
Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
Primary outcome [9] 0 0
Change in forced vital capacity (FVC) - To assess changes in FVC (Forced vital capacity) as measured by a percentage (%) predicted.
Timepoint [9] 0 0
Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
Primary outcome [10] 0 0
Change in sodium levels as part of standard serum chemistry panel. - To assess changes in sodium levels as measured in mmol/L.
Timepoint [10] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [11] 0 0
Change in potassium levels as part of standard serum chemistry panel. - To assess changes in potassium levels as measured in mmol/L.
Timepoint [11] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [12] 0 0
Change in chloride levels as part of standard serum chemistry panel. - To assess changes in chloride levels as measured in mmol/L.
Timepoint [12] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [13] 0 0
Change in bicarbonate levels as part of standard serum chemistry panel. - To assess changes in bicarbonate levels as measured in mmol/L.
Timepoint [13] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [14] 0 0
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.
Timepoint [14] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [15] 0 0
Change in creatinine levels as part of standard serum chemistry panel. - To assess changes in creatinine levels as measured in umol/L.
Timepoint [15] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [16] 0 0
Change in total protein levels as part of standard serum chemistry panel. - To assess changes in total protein levels as measured in g/L.
Timepoint [16] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [17] 0 0
Changes in total albumin levels as part of standard serum chemistry panel. - To assess changes in total albumin levels as measured in g/L.
Timepoint [17] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [18] 0 0
Change in total ALP levels as part of standard serum chemistry panel. - To assess changes in ALP levels as measured in U/L.
Timepoint [18] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [19] 0 0
Change in total ALT levels as part of standard serum chemistry panel. - To assess changes in total ALT levels as measured in U/L.
Timepoint [19] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [20] 0 0
Change in total AST levels as part of standard serum chemistry panel. - To assess changes in total AST levels as measured in U/L.
Timepoint [20] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [21] 0 0
Change in total bilirubin levels as part of standard serum chemistry panel. - To assess changes in total bilirubin levels as measured in umol/L.
Timepoint [21] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [22] 0 0
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.
Timepoint [22] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [23] 0 0
Change in total amylase levels as part of standard serum chemistry panel. - To assess changes in total amylase levels as measured in U/L.
Timepoint [23] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [24] 0 0
Change in total lipase levels as part of standard serum chemistry panel. - To assess changes in total lipase levels as measured in U/L.
Timepoint [24] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [25] 0 0
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.
Timepoint [25] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [26] 0 0
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.
Timepoint [26] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [27] 0 0
Change in total calcium levels as part of standard serum chemistry panel. - To assess changes in total calcium levels as measured in mmol/L.
Timepoint [27] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [28] 0 0
Change in total magnesium levels as part of standard serum chemistry panel. - To assess changes in total magnesium levels as measured in mmol/L.
Timepoint [28] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [29] 0 0
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.
Timepoint [29] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [30] 0 0
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.
Timepoint [30] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [31] 0 0
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.
Timepoint [31] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [32] 0 0
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.
Timepoint [32] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [33] 0 0
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.
Timepoint [33] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [34] 0 0
Change in hematocrit as part of standard hematology panel. - To assess changes in total hematocrit levels as measured by %.
Timepoint [34] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [35] 0 0
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.
Timepoint [35] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [36] 0 0
Change in platelet (PLT) counts as part of standard hematology panel. - To assess changes in platelet counts as measured by 10^9/uL.
Timepoint [36] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [37] 0 0
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.
Timepoint [37] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [38] 0 0
Change in neutrophil percentage as part of standard hematology panel. - To assess changes in neutrophil percentage as measured by %.
Timepoint [38] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [39] 0 0
Change in lymphocyte percentage as part of standard hematology panel. - To assess changes in lymphocyte percentage as measured by %.
Timepoint [39] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [40] 0 0
Change in eosinophil percentage as part of standard hematology panel. - To assess changes in eosinophil percentage as measured by %.
Timepoint [40] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [41] 0 0
Change in basophil percentage as part of standard hematology panel. - To assess changes in basophil percentage as measured by %.
Timepoint [41] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [42] 0 0
Change in monocyte percentage as part of standard hematology panel. - To assess changes in monocyte percentage as measured by %.
Timepoint [42] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [43] 0 0
Change in clarity as part of a standard urinalysis panel. - To assess changes in clarity of the urine sample.
Timepoint [43] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [44] 0 0
Change in specific gravity as part of a standard urinalysis panel. - To assess changes in specific gravity of the urine sample.
Timepoint [44] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [45] 0 0
Change in pH as part of a standard urinalysis panel. - To assess changes in pH of the urine sample.
Timepoint [45] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [46] 0 0
Change in protein levels as part of a standard urinalysis panel. - To assess changes in protein levels of the urine sample.
Timepoint [46] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [47] 0 0
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.
Timepoint [47] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [48] 0 0
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.
Timepoint [48] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [49] 0 0
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.
Timepoint [49] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [50] 0 0
Change in nitrite levels as part of a standard urinalysis panel. - To assess changes in nitrite levels of the urine sample.
Timepoint [50] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Primary outcome [51] 0 0
Change in leukocyte esterase levels as part of a standard urinalysis panel. - To assess changes in leukocyte esterase levels of the urine sample.
Timepoint [51] 0 0
Screening, day 1, day 2, day 3 and 30 days after dosing.
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
PK assessment: t1/2 (Terminal half-life) - Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
PK assessment of urine - Evaluation of PRS-060 levels in the urine after a single inhaled or IV infusion dose of PRS-060
Timepoint [9] 0 0
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

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Limited - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pieris Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Dose Escalating Study of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy
Subjects
Trial website
https://clinicaltrials.gov/show/NCT03384290
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, MBBS PhD
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications