AsthmaPhase 1NCT03574805
Study of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects With Mild Asthma
A Phase 1 study testing PRS-060 in people with Asthma, run by Pieris Australia Pty Ltd at 4 sites in Australia.
Trial summary
Study of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects with Mild Asthma Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- PRS-060
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 4 sitesAustralia
- Study dates
- 26 Jun 2018to 15 Sep 2020
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Body Mass Index (BMI) of 18 to 35
- Subjects who are non-smokers or ex-smokers who have smoked no more than twice in 3 months prior to screening (determined by urine continine < 500 ng/mL, at Screening visit)
- Males and non-pregnant, non-breastfeeding females
- Males who are sexually active with women of childbearing potential must agree to follow a highly effective method(s) of contraception for the duration of treatment with study drug as well as for an additional 90 days post-treatment completion. Women of childbearing potential who are sexually active with a fertile male must agree to follow instructions for double methods of contraception for the duration of their participation in the trial and for 90 days post-treatment completion
- Documented diagnosis of mild asthma
- 18 to 55 years of age
- Lung function ≥ 70% predicted for FEV1 and FEV1/FVC ratio ≥ 0.7
- FeNO ≥ 35 ppb at Screening and during pre-qualification for the study
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 [IFN]-γ release assay [IGRA], QuantiFERON® TB-Gold), that may put the subject at risk during participation in the study
- History of cancer within the last 10 years (20 years for breast cancer) except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured. Any history of lymphoma is not allowed
- 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
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the Principal Investigator
Show all 28Show fewer
- Significant history of recurrent ongoing 'dry eye syndrome' of any cause that may be chronic or acute, that may affect the interpretation of safety data associated with the potential for ADAs targeted to PRS-060 (structurally related to tear lipocalin)
- 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
- History of anaphylaxis following any biologic therapy and known history of allergy or reaction to any component of the investigational product formulation
- 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, or breastfeeding, or planning to become pregnant within the study period or 90 days post-treatment completion
- 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 a highly effective method of contraception from Day 1 to 90 days post-treatment completion. Females of childbearing potential who are sexually active with a fertile male partner who do not agree to double methods of contraception with at least one barrier from Day 1 to 90 days post-treatment completion
- Life-threatening asthmatic episode in the past
- C-reactive protein (CRP) above 5 mg/L
- Use of the following medicines within the specified time before screening:
- Long-acting β2 agonists; none for 4 weeks prior to Screening
- Anti-IgE or anti-IL-5 therapy; for 6 months prior to Screening
- Inhaled corticosteroids (> 500 μg per day of beclometasone dipropionate [BDP] or equivalent) within 16 weeks prior to Screening
- Inhaled corticosteroids; none for 4 weeks prior to screening
- Oral or injectable steroids for the treatment of asthma or respiratory tract infection within 5 years prior to Screening
- Intranasal steroids within 4 weeks prior to Screening
- Topical steroids within 4 weeks prior to Screening
- Leukotriene antagonists within 2 weeks prior to Screening
- Xanthines (excluding caffeine), anticholinergics, or cromoglycate within 1 week prior to Screening
- PRS-060 at anytime
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
CMAX
Adelaide, South Australia, 5000
Q-Pharm
Herston, Queensland, 4006
Nucleus Network Limited
Melbourne, Victoria, 3004
Linear
Nedlands, Western Australia, 6009
About this study
Official title: A Dose-Escalating, Single-Blind Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects With Mild Asthma
Study of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects with Mild Asthma
Read the detailed description
PRS-060 is a drug candidate being developed for the treatment of asthma. The main purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of multiple doses of PRS-060 administered by inhalation in subjects with mild asthma.
- Conditions
- Asthma
- Being tested
- PRS-060, Placebo
- Keywords
- Asthma, Anticalin, PRS-060, 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
Study drug
PlaceboDrug
Inhalant designed to mimic PRS-060
| Study group | Role | What they receive |
|---|---|---|
| PRS-060 | Active comparator | PRS-060 or Placebo Receives: Drug: PRS-060 |
| Placebo | Placebo comparator | PRS-060 or Placebo Receives: Drug: Placebo |
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 an inhaled dose of PRS-060
The number of participants with treatment related AEs as assessed by current approved CTCAE version
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 as measured in mm Hg)
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in heart rate
To assess changes in beats per minute (BPM) as a criterion of safety and tolerability variables
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in body temperature
To assess changes in body temperature in degrees Celsius as a criterion of safety and tolerability variables
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in forced expiratory volume 1-second (FEV1) as part of spirometry
To assess changes in FEV1 as measured in mL as part of spirometry
Measured: Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in forced vital capacity (FVC) as part of spirometry
To assess changes in FVC as measured by mL
Measured: Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in peak expiratory flow rate (PEFR) as part of spirometry
To assess changes in PEFR as measured in L/min
Measured: Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in sodium levels as part of standard serum chemistry panel
To asses changes in sodium levels as measured in mmol/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in potassium levels as part of standard serum chemistry panel
To assess changes in potassium levels as measured in mmol/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in chloride levels as part of standard serum chemistry panel
To assess changes in chloride levels as measured in mmol/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days)
Change in bicarbonate levels as part of standard serum chemistry panel
To assess changes in bicarbonate levels as measured in mmol/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in blood urea nitrogen (BUN)/Urea levels as part of standard serum chemistry panel
To assess changes BUN/Urea levels as measured in mmol/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in creatinine levels as part of standard serum chemistry panel
To assess changes in creatinine levels as measured in umol/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in albumin levels as part of standard serum chemistry panel
To assess changes in albumin levels as measure in g/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in alkaline phosphate (ALP) levels as part of standard serum chemistry panel
To assess changes in ALP levels as measured in U/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in ALT levels as part of standard serum chemistry panel
To assess changes in ALT levels as measured in U/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Changes in AST levels as part of standard serum chemistry panel
To assess changes in AST levels as measured in U/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in direct bilirubin levels as part of standard serum chemistry panel
To assess changes in direct bilirubin levels as measured in umol/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in indirect bilirubin levels as part of standard serum chemistry panel
To assess changes in indirect bilirubin levels as measured in umol/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in amylase levels as part of standard serum chemistry panel
To assess changes in amylase levels as measured in U/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in lipase levels as part of standard serum chemistry panel
To assess changes in lipase levels as measured in U/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in uric acid levels as part of standard serum chemistry panel
To assess changes in uric acid levels as measured in mmol/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in creatine kinase (CK) levels as part of standard serum chemistry panel
To assess changes in CK levels as measured in U/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in calcium levels as part of standard serum chemistry panel
To assess changes in calcium levels as measured in mmol/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in magnesium levels as part of standard serum chemistry panel
To assess changes in magnesium levels as measured in mmol/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in lactate dehydrogenase (LDH) levels as part of standard serum chemistry panel.
To assess changes in LDH levels as measure in U/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Changes 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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Changes in total immunoglobulin (IgE) levels as part of standard serum chemistry panel
To assess changes in total IgE levels as measured in lU/mL
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in hematocrit as part of standard hematology panel
To assess changes in total hamatocrit levels as measured by %
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in hemoglobin levels as part of standard hematology panel
To assess changes in hemoglobin levels as measured by g/L
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in red blood cells (RBC) counts as part of standard hematology panel
To assess changes in red blood cells (RBC) counts as measured by 10^12/uL
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in platelet (PLT) counts as part of standard hematology panel
To assess changes in PLT counts as measured by 10^9/uL
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in white blood cells (WBC) counts as part of standard hematology panel
To assess changes in white blood cell (WBC) counts as measured by 10^9/uL
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in neutrophil percentage as part of standard hematology panel
To assess changes in neutrophil percentages as measured by %
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in lymphocyte percentage as part of standard hematology panel
To assess changes in lymphocyte percentage as measured by %
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in eosinophil percentage a part of standard hematology panel
To assess changes in eosinophil percentage as measured by %
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in basophil percentage as part of standard hematology panel
To assess changes basophil percentages as measured by %
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in monocyte percentage as part of standard hematology panel
To assess changes in monocyte percentage as measured by %
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in clarity as part of a standard urinalysis panel
To assess changes in clarity of the urine sample
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in specific gravity as part of a standard urinalysis panel
To assess changes in specific gravity of the urine sample
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in pH as part of a standard urinalysis panel
To assess changes in pH of the urine sample
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in protein levels as part of a standard urinalysis panel
To assess changes in protein levels of the urine sample
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Change in nitrite levels as part of a standard urinalysis panel
To assess changes in nitrite levels of the urine sample
Measured: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Secondary outcomes (11)
PK assessment: Cmax (observed maximum serum concentration taken directly from the individual concentration-time curve)
Evaluation of the PK after receiving PRS-060
Measured: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment: Tmax (time to reach maximum serum concentration, taken directly from the individual concentration-time curve)
Evaluation of the PK after receiving PRS-060
Measured: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment: t1/2(terminal half-life)
Evaluation of the PK after receiving PRS-060
Measured: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 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 after receiving PRS-060
Measured: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment: AUC (area under the concentration-time curve in the serum zero [pre-dose] extrapolated to infinite time)
Evaluation of the PK after receiving PRS-060
Measured: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment: AUC (0-24) (area under the plasma concentration-curve)
Evaluation of the PK after receiving PRS-060
Measured: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment: Vz/F (apparent volume of distribution during terminal phase)
Evaluation of the PK after receiving PRS-060
Measured: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment: CL/F (apparent oral clearance estimated as dose divided by AUC)
Evaluation of the PK after receiving PRS-060
Measured: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment of urine
Evaluation of PRS-060 levels in the urine after receiving PRS-060
Measured: During treatment and confinement
Serum ADA assessment using bridging Immunoassay Enhanced Chemiluminescence (ECL) method
Evaluation of potential development of ADAs against PRS-060
Measured: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
FeNO assessment
Evaluation of FeNO after receiving PRS-060 or placebo
Measured: Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start26 Jun 2018
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pieris Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574805
- Sponsor's protocol ID
- PRS-060-PCS_07_18
- Status last verified
- Dec 2020
- First submitted
- 11 Jun 2018
- Last updated
- 24 Dec 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 24 Dec 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 Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects With Mild Asthma
- ClinicalTrials.gov ID
- NCT03574805
- Acronym / sponsor ID
- PRS-060-PCS_07_18
- Conditions
- Asthma
- Keywords
- Asthma, Anticalin, PRS-060, Pieris, IL-4 receptor alpha, IL-13, IL-4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Pieris Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 2 Jul 2018 (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.
Study of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects with Mild Asthma
Detailed description
PRS-060 is a drug candidate being developed for the treatment of asthma. The main purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of multiple doses of PRS-060 administered by inhalation in subjects with mild asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRS-060 | Active comparator | Drug: PRS-060PRS-060 or Placebo |
| Placebo | Placebo comparator | Drug: PlaceboPRS-060 or Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Body Mass Index (BMI) of 18 to 35
- Subjects who are non-smokers or ex-smokers who have smoked no more than twice in 3 months prior to screening (determined by urine continine < 500 ng/mL, at Screening visit)
- Males and non-pregnant, non-breastfeeding females
- Males who are sexually active with women of childbearing potential must agree to follow a highly effective method(s) of contraception for the duration of treatment with study drug as well as for an additional 90 days post-treatment completion. Women of childbearing potential who are sexually active with a fertile male must agree to follow instructions for double methods of contraception for the duration of their participation in the trial and for 90 days post-treatment completion
- Documented diagnosis of mild asthma
Key exclusion criteria (28 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 [IFN]-γ release assay [IGRA], QuantiFERON® TB-Gold), that may put the subject at risk during participation in the study
- History of cancer within the last 10 years (20 years for breast cancer) except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured. Any history of lymphoma is not allowed
- 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
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-060Study drug | Drug | PRS-060 |
| PlaceboInhalant designed to mimic PRS-060 | Drug | Placebo |
Primary outcome
Number of participants with adverse events (AEs) after an inhaled 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 current approved CTCAE version
Change in blood pressure
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess blood pressure (systolic and diastolic) as a criterion of safety and tolerability variables as measured in mm Hg)
Change in heart rate
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in beats per minute (BPM) as a criterion of safety and tolerability variables
Change in body temperature
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in body temperature in degrees Celsius as a criterion of safety and tolerability variables
Change in electrocardiograms (ECGs)
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables
Change in forced expiratory volume 1-second (FEV1) as part of spirometry
Time frame: Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in FEV1 as measured in mL as part of spirometry
Change in forced vital capacity (FVC) as part of spirometry
Time frame: Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in FVC as measured by mL
Change in peak expiratory flow rate (PEFR) as part of spirometry
Time frame: Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in PEFR as measured in L/min
Change in sodium levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To asses changes in sodium levels as measured in mmol/L
Change in potassium levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days)
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes BUN/Urea levels as measured in mmol/L
Change in creatinine levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in total protein levels as measured in g/L
Change in albumin levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in albumin levels as measure in g/L
Change in alkaline phosphate (ALP) levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in ALP levels as measured in U/L
Change in ALT levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in ALT levels as measured in U/L
Changes in AST levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in AST levels as measured in U/L
Change in total bilirubin levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in total bilirubin levels as measured in umol/L
Change in direct bilirubin levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in direct bilirubin levels as measured in umol/L
Change in indirect bilirubin levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in indirect bilirubin levels as measured in umol/L
Change in amylase levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in amylase levels as measured in U/L
Change in lipase levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in lipase levels as measured in U/L
Change in uric acid levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in uric acid levels as measured in mmol/L
Change in creatine kinase (CK) levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in CK levels as measured in U/L
Change in calcium levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in calcium levels as measured in mmol/L
Change in magnesium levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in magnesium levels as measured in mmol/L
Change in lactate dehydrogenase (LDH) levels as part of standard serum chemistry panel.
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in LDH levels as measure in U/L
Change in total immunoglobulin (IgG) levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in total IgG levels as measured in g/L
Changes in total immunoglobulin (IgA) levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in total IgE levels as measured in lU/mL
Change in total immunoglobulin (IgM) levels as part of standard serum chemistry panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in total IgM levels as measured in g/L
Change in hematocrit as part of standard hematology panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in total hamatocrit levels as measured by %
Change in hemoglobin levels as part of standard hematology panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in hemoglobin levels as measured by g/L
Change in red blood cells (RBC) counts as part of standard hematology panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in red blood cells (RBC) counts as measured by 10^12/uL
Change in platelet (PLT) counts as part of standard hematology panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in PLT counts as measured by 10^9/uL
Change in white blood cells (WBC) counts as part of standard hematology panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in white blood cell (WBC) counts as measured by 10^9/uL
Change in neutrophil percentage as part of standard hematology panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in neutrophil percentages as measured by %
Change in lymphocyte percentage as part of standard hematology panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in lymphocyte percentage as measured by %
Change in eosinophil percentage a part of standard hematology panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in eosinophil percentage as measured by %
Change in basophil percentage as part of standard hematology panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes basophil percentages as measured by %
Change in monocyte percentage as part of standard hematology panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in monocyte percentage as measured by %
Change in clarity as part of a standard urinalysis panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in clarity of the urine sample
Change in specific gravity as part of a standard urinalysis panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in specific gravity of the urine sample
Change in pH as part of a standard urinalysis panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in pH of the urine sample
Change in protein levels as part of a standard urinalysis panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in protein levels of the urine sample
Change in glucose levels as part of a standard urinalysis panel
Time frame: Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
To assess changes in leukocyte esterase levels of the urine sample
11 secondary outcomes
PK assessment: Cmax (observed maximum serum concentration taken directly from the individual concentration-time curve)
Time frame: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment: Tmax (time to reach maximum serum concentration, taken directly from the individual concentration-time curve)
Time frame: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment: t1/2(terminal half-life)
Time frame: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 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: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment: AUC (area under the concentration-time curve in the serum zero [pre-dose] extrapolated to infinite time)
Time frame: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment: AUC (0-24) (area under the plasma concentration-curve)
Time frame: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment: Vz/F (apparent volume of distribution during terminal phase)
Time frame: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment: CL/F (apparent oral clearance estimated as dose divided by AUC)
Time frame: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
PK assessment of urine
Time frame: During treatment and confinement
Serum ADA assessment using bridging Immunoassay Enhanced Chemiluminescence (ECL) method
Time frame: During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
FeNO assessment
Time frame: Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
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 24 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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 Asthma, run by Pieris Australia Pty Ltd at 4 sites 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 8 inclusion and 28 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 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 an inhaled dose of PRS-060 (time frame: From time of dose until 30 days after dosing). The study lists 52 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 24 Dec 2020.