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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03574805




Registration number
NCT03574805
Ethics application status
Date submitted
11/06/2018
Date registered
2/07/2018

Titles & IDs
Public title
Study of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects With Mild Asthma
Scientific 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
Secondary ID [1] 0 0
PRS-060-PCS_07_18
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

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

Active comparator: PRS-060 - PRS-060 or Placebo

Placebo comparator: Placebo - PRS-060 or Placebo


Treatment: Drugs: PRS-060
Study drug

Treatment: Drugs: Placebo
Inhalant designed to mimic PRS-060
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 an inhaled dose of PRS-060
Timepoint [1] 0 0
From time of dose until 30 days after dosing
Primary outcome [2] 0 0
Change in blood pressure
Timepoint [2] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [3] 0 0
Change in heart rate
Timepoint [3] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [4] 0 0
Change in body temperature
Timepoint [4] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [5] 0 0
Change in electrocardiograms (ECGs)
Timepoint [5] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [6] 0 0
Change in forced expiratory volume 1-second (FEV1) as part of spirometry
Timepoint [6] 0 0
Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [7] 0 0
Change in forced vital capacity (FVC) as part of spirometry
Timepoint [7] 0 0
Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [8] 0 0
Change in peak expiratory flow rate (PEFR) as part of spirometry
Timepoint [8] 0 0
Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [9] 0 0
Change in sodium levels as part of standard serum chemistry panel
Timepoint [9] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [10] 0 0
Change in potassium levels as part of standard serum chemistry panel
Timepoint [10] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [11] 0 0
Change in chloride levels as part of standard serum chemistry panel
Timepoint [11] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days)
Primary outcome [12] 0 0
Change in bicarbonate levels as part of standard serum chemistry panel
Timepoint [12] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [13] 0 0
Change in blood urea nitrogen (BUN)/Urea levels as part of standard serum chemistry panel
Timepoint [13] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [14] 0 0
Change in creatinine levels as part of standard serum chemistry panel
Timepoint [14] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [15] 0 0
Change in total protein levels as part of standard serum chemistry panel
Timepoint [15] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [16] 0 0
Change in albumin levels as part of standard serum chemistry panel
Timepoint [16] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [17] 0 0
Change in alkaline phosphate (ALP) levels as part of standard serum chemistry panel
Timepoint [17] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [18] 0 0
Change in ALT levels as part of standard serum chemistry panel
Timepoint [18] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [19] 0 0
Changes in AST levels as part of standard serum chemistry panel
Timepoint [19] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [20] 0 0
Change in total bilirubin levels as part of standard serum chemistry panel
Timepoint [20] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [21] 0 0
Change in direct bilirubin levels as part of standard serum chemistry panel
Timepoint [21] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [22] 0 0
Change in indirect bilirubin levels as part of standard serum chemistry panel
Timepoint [22] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [23] 0 0
Change in amylase levels as part of standard serum chemistry panel
Timepoint [23] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [24] 0 0
Change in lipase levels as part of standard serum chemistry panel
Timepoint [24] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [25] 0 0
Change in uric acid levels as part of standard serum chemistry panel
Timepoint [25] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [26] 0 0
Change in creatine kinase (CK) levels as part of standard serum chemistry panel
Timepoint [26] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [27] 0 0
Change in calcium levels as part of standard serum chemistry panel
Timepoint [27] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [28] 0 0
Change in magnesium levels as part of standard serum chemistry panel
Timepoint [28] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [29] 0 0
Change in lactate dehydrogenase (LDH) levels as part of standard serum chemistry panel.
Timepoint [29] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [30] 0 0
Change in total immunoglobulin (IgG) levels as part of standard serum chemistry panel
Timepoint [30] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [31] 0 0
Changes in total immunoglobulin (IgA) levels as part of standard serum chemistry panel
Timepoint [31] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [32] 0 0
Changes in total immunoglobulin (IgE) levels as part of standard serum chemistry panel
Timepoint [32] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [33] 0 0
Change in total immunoglobulin (IgM) levels as part of standard serum chemistry panel
Timepoint [33] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [34] 0 0
Change in hematocrit as part of standard hematology panel
Timepoint [34] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [35] 0 0
Change in hemoglobin levels as part of standard hematology panel
Timepoint [35] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [36] 0 0
Change in red blood cells (RBC) counts as part of standard hematology panel
Timepoint [36] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [37] 0 0
Change in platelet (PLT) counts as part of standard hematology panel
Timepoint [37] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [38] 0 0
Change in white blood cells (WBC) counts as part of standard hematology panel
Timepoint [38] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [39] 0 0
Change in neutrophil percentage as part of standard hematology panel
Timepoint [39] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [40] 0 0
Change in lymphocyte percentage as part of standard hematology panel
Timepoint [40] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [41] 0 0
Change in eosinophil percentage a part of standard hematology panel
Timepoint [41] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [42] 0 0
Change in basophil percentage as part of standard hematology panel
Timepoint [42] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [43] 0 0
Change in monocyte percentage as part of standard hematology panel
Timepoint [43] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [44] 0 0
Change in clarity as part of a standard urinalysis panel
Timepoint [44] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [45] 0 0
Change in specific gravity as part of a standard urinalysis panel
Timepoint [45] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [46] 0 0
Change in pH as part of a standard urinalysis panel
Timepoint [46] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [47] 0 0
Change in protein levels as part of a standard urinalysis panel
Timepoint [47] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [48] 0 0
Change in glucose levels as part of a standard urinalysis panel
Timepoint [48] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [49] 0 0
Change in ketone levels as part of a standard urinalysis panel
Timepoint [49] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [50] 0 0
Change in blood levels as part of a standard urinalysis panel
Timepoint [50] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [51] 0 0
Change in nitrite levels as part of a standard urinalysis panel
Timepoint [51] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Primary outcome [52] 0 0
Change in leukocyte esterase levels as part of a standard urinalysis panel
Timepoint [52] 0 0
Screening, during treatment, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Secondary outcome [1] 0 0
PK assessment: Cmax (observed maximum serum concentration taken directly from the individual concentration-time curve)
Timepoint [1] 0 0
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Secondary outcome [2] 0 0
PK assessment: Tmax (time to reach maximum serum concentration, taken directly from the individual concentration-time curve)
Timepoint [2] 0 0
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Secondary outcome [3] 0 0
PK assessment: t1/2(terminal half-life)
Timepoint [3] 0 0
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 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)
Timepoint [4] 0 0
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 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)
Timepoint [5] 0 0
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Secondary outcome [6] 0 0
PK assessment: AUC (0-24) (area under the plasma concentration-curve)
Timepoint [6] 0 0
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Secondary outcome [7] 0 0
PK assessment: Vz/F (apparent volume of distribution during terminal phase)
Timepoint [7] 0 0
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Secondary outcome [8] 0 0
PK assessment: CL/F (apparent oral clearance estimated as dose divided by AUC)
Timepoint [8] 0 0
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Secondary outcome [9] 0 0
PK assessment of urine
Timepoint [9] 0 0
During treatment and confinement
Secondary outcome [10] 0 0
Serum ADA assessment using bridging Immunoassay Enhanced Chemiluminescence (ECL) method
Timepoint [10] 0 0
During treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).
Secondary outcome [11] 0 0
FeNO assessment
Timepoint [11] 0 0
Screening, during treatment and confinement, 7 days after dosing (±1 day), and 30 days after dosing (±3 days).

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 [IFN]-? 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
* 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 ß2 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

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
26/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/09/2020
Sample size
Target
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,West Australi
Recruitment hospital [1] 0 0
Q-Pharm - Herston
Recruitment hospital [2] 0 0
CMAX - Adelaide
Recruitment hospital [3] 0 0
Nucleus Network Limited - Melbourne
Recruitment hospital [4] 0 0
Linear - Nedlands
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03574805