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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05473533
Registration number
NCT05473533
Ethics application status
Date submitted
19/07/2022
Date registered
26/07/2022
Date last updated
23/10/2023
Titles & IDs
Public title
Study of Single and Multiple Doses of PRS-220 Administered by Oral Inhalation in Healthy Subjects
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Scientific title
A Phase 1, Randomized, Blinded, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of PRS 220 Administered by Oral Inhalation in Healthy Subjects.
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Secondary ID [1]
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0
PRS-220-PCS_11_21
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Respiratory
0
0
0
0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - PRS-220
Placebo Comparator: Arm 1 - Placebo
Experimental: Arm 2 - PRS-220
Treatment: Drugs: Placebo
Placebo; formulated as solution for inhalation without active substance.
Treatment: Drugs: PRS-220
PRS-220; formulated as solution for inhalation.
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety & tolerability - AEs
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Assessment method [1]
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The safety and tolerability of PRS-220 will be assessed based on the frequency (no. per patient, cohort, and treatment [PRS-220 vs. placebo]) and severity (based on the Common Terminology Criteria for Adverse Events, CTCAE) of adverse events (AEs) throughout the study and until 28 days after the last dose.
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Timepoint [1]
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29 days (SAD), 57 days (MAD)
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Primary outcome [2]
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Safety & tolerability - SAEs
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Assessment method [2]
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0
The safety and tolerability of PRS-220 will be assessed based on the frequency (no. per patient, cohort, and treatment [PRS-220 vs. placebo]) and severity (based on the Common Terminology Criteria for Adverse Events, CTCAE) of serious adverse events (SAEs) throughout the study and until 28 days after the last dose.
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Timepoint [2]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [3]
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Safety & tolerability - TEAEs
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Assessment method [3]
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0
The safety and tolerability of PRS-220 will be assessed based on the frequency (no. per patient, cohort, and treatment [PRS-220 vs. placebo]) and severity (based on the Common Terminology Criteria for Adverse Events, CTCAE) of treatment-emergent adverse events (TEAEs) throughout the study and until 28 days after the last dose.
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Timepoint [3]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [4]
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0
Safety & tolerability - Vital signs (change in blood pressure)
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Assessment method [4]
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To assess changes in blood pressure (systolic and diastolic, mm Hg) as a criterion of safety and tolerability throughout the study.
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Timepoint [4]
0
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29 days (SAD), 57 days (MAD)
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Primary outcome [5]
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Safety & tolerability - Vital signs (change in heart rate)
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Assessment method [5]
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To assess changes in heart rate (beats per minute, BPM) as a criterion of safety and tolerability throughout the study.
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Timepoint [5]
0
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29 days (SAD), 57 days (MAD)
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Primary outcome [6]
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Safety & tolerability - Vital signs (change in body temperature)
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Assessment method [6]
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To assess changes in body temperature (degrees Celsius) as a criterion of safety and tolerability throughout the study.
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Timepoint [6]
0
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29 days (SAD), 57 days (MAD)
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Primary outcome [7]
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Safety & tolerability - Vital signs (change in respiratory rate)
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Assessment method [7]
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To assess changes in respiratory rate (breaths per minute) as a criterion of safety and tolerability throughout the study.
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Timepoint [7]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [8]
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Safety & tolerability - Vital signs (change in oxygen saturation)
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Assessment method [8]
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To assess changes in oxygen saturation (sO2, %) as a criterion of safety and tolerability throughout the study.
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Timepoint [8]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [9]
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Safety & tolerability - 12-lead ECGs
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Assessment method [9]
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0
To assess changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability throughout the study.
12-lead ECGs will be assessed by a central reader.
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Timepoint [9]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [10]
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0
Safety & tolerability - Spirometry (FEV1)
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Assessment method [10]
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0
To assess changes in FEV1 (forced expiratory volume in one second, L) as a criterion of safety and tolerability throughout the study.
Spirometry recordings will be assessed by a central reader.
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Timepoint [10]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [11]
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0
Safety & tolerability - Spirometry (PEFR)
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Assessment method [11]
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0
To assess changes in PEFR (peak expiratory flow rate, L/s) as a criterion of safety and tolerability throughout the study.
Spirometry recordings will be assessed by a central reader.
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Timepoint [11]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [12]
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0
Safety & tolerability - Spirometry (FVC)
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Assessment method [12]
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0
To assess changes in FVC (forced vital capacity, % predicted) as a criterion of safety and tolerability throughout the study.
Spirometry recordings will be assessed by a central reader.
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Timepoint [12]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [13]
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0
Safety & tolerability - Serum chemistry (sodium)
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Assessment method [13]
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0
To assess changes in sodium levels (mmol/L) throughout the study.
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Timepoint [13]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [14]
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0
Safety & tolerability - Serum chemistry (potassium)
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Assessment method [14]
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0
To assess changes in potassium levels (mmol/L) throughout the study.
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Timepoint [14]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [15]
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Safety & tolerability - Serum chemistry (chloride)
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Assessment method [15]
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0
To assess changes in chloride levels (mmol/L) throughout the study.
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Timepoint [15]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [16]
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Safety & tolerability - Serum chemistry (calcium)
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Assessment method [16]
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0
To assess changes in calcium levels (mmol/L) throughout the study.
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Timepoint [16]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [17]
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Safety & tolerability - Serum chemistry (magnesium)
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Assessment method [17]
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0
To assess changes in magnesium levels (mmol/L) throughout the study.
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Timepoint [17]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [18]
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0
Safety & tolerability - Serum chemistry (bicarbonate)
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Assessment method [18]
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0
To assess changes in bicarbonate levels (mmol/L) throughout the study.
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Timepoint [18]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [19]
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0
Safety & tolerability - Serum chemistry (urea/urea nitrogen)
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Assessment method [19]
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0
To assess changes in urea/urea nitrogen (BUN) levels (mmol/L) throughout the study.
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Timepoint [19]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [20]
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Safety & tolerability - Serum chemistry (creatinine)
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Assessment method [20]
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0
To assess changes in creatinine levels (µmol/L) throughout the study.
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Timepoint [20]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [21]
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Safety & tolerability - Serum chemistry (albumin)
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Assessment method [21]
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To assess changes in albumin levels (g/L) throughout the study.
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Timepoint [21]
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29 days (SAD), 57 days (MAD)
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Primary outcome [22]
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Safety & tolerability - Serum chemistry (bilirubin)
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Assessment method [22]
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To assess changes in bilirubin levels (µmol/L) throughout the study.
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Timepoint [22]
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29 days (SAD), 57 days (MAD)
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Primary outcome [23]
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Safety & tolerability - Serum chemistry (uric acid)
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Assessment method [23]
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0
To assess changes in uric acid levels (mmol/L) throughout the study.
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Timepoint [23]
0
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29 days (SAD), 57 days (MAD)
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Primary outcome [24]
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Safety & tolerability - Serum chemistry (creatine kinase)
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Assessment method [24]
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0
To assess changes in creatine kinase (CK) levels (U/L) throughout the study.
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Timepoint [24]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [25]
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0
Safety & tolerability - Serum chemistry (lactate dehydrogenase)
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Assessment method [25]
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0
To assess changes in lactate dehydrogenase (LDH) levels (U/L) throughout the study.
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Timepoint [25]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [26]
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Safety & tolerability - Hematology (hematocrit)
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Assessment method [26]
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0
To assess changes in hematocrit levels (%) throughout the study.
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Timepoint [26]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [27]
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Safety & tolerability - Hematology (red blood cell count)
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Assessment method [27]
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0
To assess changes in total red blood cell (RVC) counts (10^6/µL) throughout the study.
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Timepoint [27]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [28]
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0
Safety & tolerability - Hematology (platelet count)
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Assessment method [28]
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0
To assess changes in platelet counts (10^9/µL) throughout the study.
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Timepoint [28]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [29]
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0
Safety & tolerability - Hematology (white blood cell count)
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Assessment method [29]
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0
To assess changes in white blood cell (WBC) counts (10^3/µL) throughout the study.
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Timepoint [29]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [30]
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0
Safety & tolerability - Hematology (neutrophil percentage)
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Assessment method [30]
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0
To assess changes in neutrophil percentage (%) throughout the study.
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Timepoint [30]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [31]
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Safety & tolerability - Hematology (lymphocyte percentage)
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Assessment method [31]
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0
To assess changes in lymphocyte percentage (%) throughout the study.
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Timepoint [31]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [32]
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Safety & tolerability - Hematology (eosinophil percentage)
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Assessment method [32]
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0
To assess changes in eosinophil percentage (%) throughout the study.
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Timepoint [32]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [33]
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0
Safety & tolerability - Hematology (basophil percentage)
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Assessment method [33]
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0
To assess changes in basophil percentage (%) throughout the study.
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Timepoint [33]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [34]
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0
Safety & tolerability - Hematology (monocyte percentage)
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Assessment method [34]
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0
To assess changes in monocyte percentage (%) throughout the study.
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Timepoint [34]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [35]
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0
Safety & tolerability - Urinalysis (turbidity)
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Assessment method [35]
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0
To assess changes in turbidity of the urine sample as part of a standard urinalysis panel throughout the study.
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Timepoint [35]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [36]
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0
Safety & tolerability - Urinalysis (specific gravity)
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Assessment method [36]
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0
To assess changes in specific gravity of the urine sample as part of a standard urinalysis panel throughout the study.
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Timepoint [36]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [37]
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0
Safety & tolerability - Urinalysis (pH)
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Assessment method [37]
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0
To assess changes in pH of the urine sample as part of a standard urinalysis panel throughout the study.
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Timepoint [37]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [38]
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Safety & tolerability - Urinalysis (protein)
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Assessment method [38]
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0
To assess changes in protein levels of the urine sample as part of a standard urinalysis panel throughout the study.
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Timepoint [38]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [39]
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0
Safety & tolerability - Urinalysis (glucose)
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Assessment method [39]
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0
To assess changes in glucose levels (positive/negative) of the urine sample as part of a standard urinalysis panel throughout the study.
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Timepoint [39]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [40]
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0
Safety & tolerability - Urinalysis (ketone)
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Assessment method [40]
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0
To assess changes in ketone levels (positive/negative) of the urine sample as part of a standard urinalysis panel throughout the study.
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Timepoint [40]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [41]
0
0
Safety & tolerability - Urinalysis (blood)
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Assessment method [41]
0
0
To assess changes in blood levels (positive/negative) of the urine sample as part of a standard urinalysis panel throughout the study.
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Timepoint [41]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [42]
0
0
Safety & tolerability - Urinalysis (nitrite)
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Assessment method [42]
0
0
To assess changes in nitrite levels (positive/negative) of the urine sample as part of a standard urinalysis panel throughout the study.
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Timepoint [42]
0
0
29 days (SAD), 57 days (MAD)
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Primary outcome [43]
0
0
Tolerability - Taste characteristics
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Assessment method [43]
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0
Tolerability will be assessed by an open-ended questionnaire that assesses the taste characteristics of PRS-220.
Subjects must choose between values from 0 to 10; where "0" represents no/low agreement with the statement and "10" represents extreme/definite agreement with the statement.
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Timepoint [43]
0
0
Once after first dose on Day 1 (SAD, MAD) and again on Day 15 (MAD)
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Secondary outcome [1]
0
0
Pharmacokinetics of PRS-220 - Serum concentrations (AUC0-t)
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Assessment method [1]
0
0
- Area under the serum concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
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Timepoint [1]
0
0
29 days (SAD), 57 days (MAD)
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Secondary outcome [2]
0
0
Pharmacokinetics of PRS-220 - Serum concentrations (AUC0-inf)
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Assessment method [2]
0
0
- AUC from time 0 extrapolated to infinity (Day 1) (AUC0-inf)
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Timepoint [2]
0
0
29 days (SAD), 57 days (MAD)
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Secondary outcome [3]
0
0
Pharmacokinetics of PRS-220 - Serum concentrations (AUC0-tau)
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Assessment method [3]
0
0
- AUC from time 0 to the time of the dosing interval (tau; AUC0-tau); tau = 12 h
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Timepoint [3]
0
0
29 days (SAD), 57 days (MAD)
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Secondary outcome [4]
0
0
Pharmacokinetics of PRS-220 - Serum concentrations (AR)
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Assessment method [4]
0
0
- Accumulation ratio (AR), calculated during the multiple ascending dose (MAD) portion as AUC0-tau (Day 29)/AUC0-tau (Day 1); tau = 12 h
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Timepoint [4]
0
0
29 days (SAD), 57 days (MAD)
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Secondary outcome [5]
0
0
Pharmacokinetics of PRS-220 - Serum concentrations (Cmax)
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Assessment method [5]
0
0
- Maximum observed serum concentration (Cmax)
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Timepoint [5]
0
0
29 days (SAD), 57 days (MAD)
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Secondary outcome [6]
0
0
Pharmacokinetics of PRS-220 - Serum concentrations (Tmax)
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Assessment method [6]
0
0
- Time to reach maximum observed serum concentration (Tmax)
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Timepoint [6]
0
0
29 days (SAD), 57 days (MAD)
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Secondary outcome [7]
0
0
Pharmacokinetics of PRS-220 - Serum concentrations (Kel)
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Assessment method [7]
0
0
- Terminal elimination rate constant (Kel)
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Timepoint [7]
0
0
29 days (SAD), 57 days (MAD)
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Secondary outcome [8]
0
0
Pharmacokinetics of PRS-220 - Serum concentrations (t1/2)
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Assessment method [8]
0
0
- Terminal elimination half-life (t1/2)
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Timepoint [8]
0
0
29 days (SAD), 57 days (MAD)
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Secondary outcome [9]
0
0
Pharmacokinetics of PRS-220 - Serum concentrations (MRT)
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Assessment method [9]
0
0
- Mean residence time (MRT)
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Timepoint [9]
0
0
29 days (SAD), 57 days (MAD)
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Secondary outcome [10]
0
0
Immunogenicity - Anti-drug antibodies (ADA)
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Assessment method [10]
0
0
Immunogenicity potential of PRS-220 will be assessed by the presence and titer of anti-drug antibodies (ADA) in the serum.
Query!
Timepoint [10]
0
0
29 days (SAD), 57 days (MAD)
Query!
Eligibility
Key inclusion criteria
1. The subject is able to provide written ICF prior to Screening.
2. The subject is healthy male or female (only if female satisfies criteria to be
classified as a "woman of non-childbearing potential"), between the ages of 18 and 64
(inclusive) at Screening.
• Women of non-childbearing potential are defined as:
- Post-menopausal (12 consecutive months of spontaneous amenorrhea without an
alternative medical cause); or is
- Surgically sterile (having undergone one of the following procedures:
hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) and at least
six weeks post-sterilization.
Males must be surgically sterile or abstinent or not engaged in sexual relations with
a woman of childbearing potential (WOCBP) or, if engaged in sexual relations with a
WOCBP, the subject must agree to consistently use an adequate method of contraception,
which is defined as use of a condom by the male partner combined with use of a highly
effective method of contraception by the female partner. A highly effective method of
contraception is one that has a failure rate of < 1% when used consistently and
correctly.
3. The subject has a body mass index (BMI) between18 and 32 kg/m2 (inclusive) at
Screening.
4. The subject has a forced expiratory volume in one second (FEV1) =80% of the predicted
value at Screening.
5. Percent predicted forced expiratory volume in one second (ppFEV1) measurements during
Screening (any time between Day -28 and Day -2) and Check-in (Day -1) (at least 3 days
apart; and, centrally confirmed) with absolute difference <10 percentage units,
ppFEV1.
6. The subject agrees to comply with all protocol requirements.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
64
Years
Query!
Query!
Sex
Both males and females
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Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
1. The subject has clinically significant (at the discretion of the investigator)
abnormalities in physical examination, vital signs, hematology/chemistry/urinalysis,
or ECG at Screening that would render a subject unsuitable for inclusion. Including
but not limited to:
- Alanine aminotransferase (ALT) >1.5× upper limit of normal (ULN), aspartate
aminotransferase (AST) >1.5× ULN, gamma-glutamyl transferase (GGT) >1.5× ULN, or
alkaline phosphatase >1.5× ULN
- C-reactive protein (CRP) >2.9 mg/L
- After at least five minutes of supine rest, have a systolic blood pressure <90 or
>140 mmHg or diastolic blood pressure <40 or >90 mmHg at Screening
2. The subject has any significant medical condition that may put the subject at risk if
participating in this study, at the discretion of the investigator (resolved childhood
asthma can be included).
3. The subject has a history of malignancy within the past five years, except for basal
cell carcinoma, squamous cell carcinoma, and cervical cancer in situ.
4. The subject has upper respiratory tract infections within 14 days prior to the first
dose of the study drug product (Day 1); or lower respiratory tract infection within
three months prior to Screening (with regard to COVID 19, sites should adhere to local
guidelines).
5. The subject has any clinically significant illness, medical/surgical procedure, or
trauma within eight weeks prior to the first dose of the study drug product (Day 1).
6. The subject has any history of smoking (e.g., cigarettes, e-cigarettes/vaping,
marijuana, cigars) within one month prior to Screening.
7. The subject has received treatment with another investigational drug product within
the past 30 days (or five half-lives or the length of the drug's pharmacodynamic
effect, whichever is longer) prior to the first dose of the study drug product (Day
1).
8. The subject has a history of severe allergic reaction to any component of PRS-220
including its excipients.
9. The subject has a history of alcohol and/or other substance abuse or addiction within
12 months prior to Screening, as determined by the investigator, or a positive test
result for alcohol or drugs of abuse at Screening or prior to the first dose of the
study drug product (Day 1).
10. The subject has taken any of the following medications:
- Prescription medication or herbal supplements within 14 days (or five half-lives,
whichever is longer) prior to the first dose of the study drug product
- Non-prescription medication, vitamins (e.g., biotin), or minerals within seven
days prior to the first dose of the study drug product
Note: Acetaminophen (paracetamol, <4 g per day), nonsteroidal anti-inflammatory drugs
(NSAID) medication, or salicylic acid containing topical preparation may be used
within one day prior to the first dose of the study drug product.
11. The subject is consuming excessive amounts of caffeine, defined as more than four
servings of coffee, tea, cola, or other caffeinated beverages per day (one serving is
approximately 120 mg of caffeine); or the subject refuses to abstain from
caffeine-containing foods or caffeinated beverages (e.g., coffee, tea, cola, energy
drinks) within three days prior to Day -1 and until discharge from the clinical
research unit.
12. The subject has previously enrolled in this study.
13. The subject has a positive test result for hepatitis B surface antigen, hepatitis C
virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at
Screening.
14. The subject has donated blood or blood products >450 mL within 30 days before the
first dose of study drug product. The subject has donated plasma >450 mL within seven
days prior to the first dose of the study drug product.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
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Other design features
Query!
Phase
Phase 1
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Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
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Actual
31/10/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/08/2023
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Sample size
Target
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Accrual to date
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Final
64
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Nucleus Network Pty Ltd. - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pieris Australia Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A dose escalating study of PRS-220 administered by oral inhalation in healthy subjects
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05473533
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/ct2/show/NCT05473533
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