Healthy SubjectsPhase 1NCT03384290
Study of a Single Dose of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects
A Phase 1 study testing PRS-060 in people with Healthy Subjects, run by Pieris Australia Pty Ltd at 1 site in Australia.
Trial summary
A Dose Escalating Study of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- PRS-060
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Dec 2017to 11 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
A Dose Escalating Study of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects
Read the 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
- Conditions
- Healthy Subjects
- Being tested
- PRS-060, Placebo
- Keywords
- Asthma, Anticalin, PRS-060, Healthy Volunteers, Pieris, IL-4 receptor alpha, IL-13, IL-4
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRS-060Drug
Drug
PlaceboDrug
PRS-060 Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| PRS-060 | Experimental | Not described Receives: Drug: PRS-060 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-dose and post-dose at 5,10, 20 minutes,1 and 4 hours
Change in FEV6 (Forced expiratory volume 6-seconds)
To assess changes in FEV6 (Forced expiratory volume 6-seconds) as measured in L.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 %.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 %.
Measured: 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 %.
Measured: 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 %.
Measured: 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 %.
Measured: 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 %.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening, day 1, day 2, day 3 and 30 days after dosing.
Secondary outcomes (9)
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
Measured: 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)
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start8 Dec 2017
- Primary completion11 Oct 2018
- Study completion11 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pieris Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Lickliter, MBBS PhD, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384290
- Sponsor's protocol ID
- PRS-060-PCS_06_17
- Status last verified
- Nov 2020
- First submitted
- 26 Nov 2017
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03384290
- Acronym / sponsor ID
- PRS-060-PCS_06_17
- Conditions
- Healthy Subjects
- Keywords
- Asthma, Anticalin, PRS-060, Healthy Volunteers, Pieris, IL-4 receptor alpha, IL-13, IL-4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Pieris Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| PRS-060 | Experimental | Drug: PRS-060 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRS-060Drug | Drug | PRS-060 |
| PlaceboPRS-060 Matching Placebo | Drug | Placebo |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 %.
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.
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.
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.
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 %.
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 %.
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 %.
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 %.
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 %.
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.
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.
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.
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.
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.
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.
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.
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.
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.
9 secondary outcomes
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
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)
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Lickliter, MBBS PhD principal investigator
Nucleus Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRS-060 in people with Healthy Subjects, run by Pieris Australia Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 51 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.