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CompletedNCT05473533Updated Oct 23, 2023

Study of Single and Multiple Doses of PRS-220 Administered by Oral Inhalation in Healthy Subjects

A Phase 1 interventional study of Placebo and PRS-220 in Healthy, sponsored by Pieris Australia Pty Ltd. Completed at 1 site in Australia. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by Pieris Australia Pty Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

A dose escalating study of PRS-220 administered by oral inhalation in healthy subjects

Read the detailed description

PRS-220 is a new drug being developed for treatment of idiopathic pulmonary fibrosis (IPF). The main purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple ascending doses of PRS-220 in healthy subjects.

02

Conditions studied

  • Healthy

Keywords

  • Idiopathic pulmonary fibrosis (IPF)
  • Anticalin
  • PRS-220
  • Healthy Volunteers
  • Pieris
  • CTGF
03

In context

Idiopathic Pulmonary Fibrosis

565 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.

This study's enrollment of 64 is above the median of 55 across 388 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Pieris Australia Pty Ltd is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Placebo comparator
    Arm 1

    Placebo

    Drug: Placebo

  • Experimental
    Arm 2

    PRS-220

    Drug: PRS-220

Interventions

  • DrugPlacebo

    Placebo; formulated as solution for inhalation without active substance.

    Also known as: Control

  • DrugPRS-220

    PRS-220; formulated as solution for inhalation.

    Also known as: Active

06

What researchers measure

Primary outcomes

  1. Safety & tolerability - AEs

    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.

    Time frame: 29 days (SAD), 57 days (MAD)

  2. Safety & tolerability - SAEs

    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.

    Time frame: 29 days (SAD), 57 days (MAD)

  3. Safety & tolerability - TEAEs

    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.

    Time frame: 29 days (SAD), 57 days (MAD)

  4. Safety & tolerability - Vital signs (change in blood pressure)

    To assess changes in blood pressure (systolic and diastolic, mm Hg) as a criterion of safety and tolerability throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  5. Safety & tolerability - Vital signs (change in heart rate)

    To assess changes in heart rate (beats per minute, BPM) as a criterion of safety and tolerability throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  6. Safety & tolerability - Vital signs (change in body temperature)

    To assess changes in body temperature (degrees Celsius) as a criterion of safety and tolerability throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  7. Safety & tolerability - Vital signs (change in respiratory rate)

    To assess changes in respiratory rate (breaths per minute) as a criterion of safety and tolerability throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  8. Safety & tolerability - Vital signs (change in oxygen saturation)

    To assess changes in oxygen saturation (sO2, %) as a criterion of safety and tolerability throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  9. Safety & tolerability - 12-lead ECGs

    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.

    Time frame: 29 days (SAD), 57 days (MAD)

  10. Safety & tolerability - Spirometry (FEV1)

    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.

    Time frame: 29 days (SAD), 57 days (MAD)

  11. Safety & tolerability - Spirometry (PEFR)

    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.

    Time frame: 29 days (SAD), 57 days (MAD)

  12. Safety & tolerability - Spirometry (FVC)

    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.

    Time frame: 29 days (SAD), 57 days (MAD)

  13. Safety & tolerability - Serum chemistry (sodium)

    To assess changes in sodium levels (mmol/L) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  14. Safety & tolerability - Serum chemistry (potassium)

    To assess changes in potassium levels (mmol/L) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  15. Safety & tolerability - Serum chemistry (chloride)

    To assess changes in chloride levels (mmol/L) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  16. Safety & tolerability - Serum chemistry (calcium)

    To assess changes in calcium levels (mmol/L) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  17. Safety & tolerability - Serum chemistry (magnesium)

    To assess changes in magnesium levels (mmol/L) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  18. Safety & tolerability - Serum chemistry (bicarbonate)

    To assess changes in bicarbonate levels (mmol/L) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  19. Safety & tolerability - Serum chemistry (urea/urea nitrogen)

    To assess changes in urea/urea nitrogen (BUN) levels (mmol/L) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  20. Safety & tolerability - Serum chemistry (creatinine)

    To assess changes in creatinine levels (µmol/L) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  21. Safety & tolerability - Serum chemistry (albumin)

    To assess changes in albumin levels (g/L) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  22. Safety & tolerability - Serum chemistry (bilirubin)

    To assess changes in bilirubin levels (µmol/L) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  23. Safety & tolerability - Serum chemistry (uric acid)

    To assess changes in uric acid levels (mmol/L) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  24. Safety & tolerability - Serum chemistry (creatine kinase)

    To assess changes in creatine kinase (CK) levels (U/L) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  25. Safety & tolerability - Serum chemistry (lactate dehydrogenase)

    To assess changes in lactate dehydrogenase (LDH) levels (U/L) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  26. Safety & tolerability - Hematology (hematocrit)

    To assess changes in hematocrit levels (%) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  27. Safety & tolerability - Hematology (red blood cell count)

    To assess changes in total red blood cell (RVC) counts (10\^6/µL) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  28. Safety & tolerability - Hematology (platelet count)

    To assess changes in platelet counts (10\^9/µL) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  29. Safety & tolerability - Hematology (white blood cell count)

    To assess changes in white blood cell (WBC) counts (10\^3/µL) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  30. Safety & tolerability - Hematology (neutrophil percentage)

    To assess changes in neutrophil percentage (%) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  31. Safety & tolerability - Hematology (lymphocyte percentage)

    To assess changes in lymphocyte percentage (%) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  32. Safety & tolerability - Hematology (eosinophil percentage)

    To assess changes in eosinophil percentage (%) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  33. Safety & tolerability - Hematology (basophil percentage)

    To assess changes in basophil percentage (%) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  34. Safety & tolerability - Hematology (monocyte percentage)

    To assess changes in monocyte percentage (%) throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  35. Safety & tolerability - Urinalysis (turbidity)

    To assess changes in turbidity of the urine sample as part of a standard urinalysis panel throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  36. Safety & tolerability - Urinalysis (specific gravity)

    To assess changes in specific gravity of the urine sample as part of a standard urinalysis panel throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  37. Safety & tolerability - Urinalysis (pH)

    To assess changes in pH of the urine sample as part of a standard urinalysis panel throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  38. Safety & tolerability - Urinalysis (protein)

    To assess changes in protein levels of the urine sample as part of a standard urinalysis panel throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  39. Safety & tolerability - Urinalysis (glucose)

    To assess changes in glucose levels (positive/negative) of the urine sample as part of a standard urinalysis panel throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  40. Safety & tolerability - Urinalysis (ketone)

    To assess changes in ketone levels (positive/negative) of the urine sample as part of a standard urinalysis panel throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  41. Safety & tolerability - Urinalysis (blood)

    To assess changes in blood levels (positive/negative) of the urine sample as part of a standard urinalysis panel throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  42. Safety & tolerability - Urinalysis (nitrite)

    To assess changes in nitrite levels (positive/negative) of the urine sample as part of a standard urinalysis panel throughout the study.

    Time frame: 29 days (SAD), 57 days (MAD)

  43. Tolerability - Taste characteristics

    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.

    Time frame: Once after first dose on Day 1 (SAD, MAD) and again on Day 15 (MAD)

Secondary outcomes

  1. Pharmacokinetics of PRS-220 - Serum concentrations (AUC0-t)

    \- Area under the serum concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)

    Time frame: 29 days (SAD), 57 days (MAD)

  2. Pharmacokinetics of PRS-220 - Serum concentrations (AUC0-inf)

    \- AUC from time 0 extrapolated to infinity (Day 1) (AUC0-inf)

    Time frame: 29 days (SAD), 57 days (MAD)

  3. Pharmacokinetics of PRS-220 - Serum concentrations (AUC0-tau)

    \- AUC from time 0 to the time of the dosing interval (tau; AUC0-tau); tau = 12 h

    Time frame: 29 days (SAD), 57 days (MAD)

  4. Pharmacokinetics of PRS-220 - Serum concentrations (AR)

    \- Accumulation ratio (AR), calculated during the multiple ascending dose (MAD) portion as AUC0-tau (Day 29)/AUC0-tau (Day 1); tau = 12 h

    Time frame: 29 days (SAD), 57 days (MAD)

  5. Pharmacokinetics of PRS-220 - Serum concentrations (Cmax)

    \- Maximum observed serum concentration (Cmax)

    Time frame: 29 days (SAD), 57 days (MAD)

  6. Pharmacokinetics of PRS-220 - Serum concentrations (Tmax)

    \- Time to reach maximum observed serum concentration (Tmax)

    Time frame: 29 days (SAD), 57 days (MAD)

  7. Pharmacokinetics of PRS-220 - Serum concentrations (Kel)

    \- Terminal elimination rate constant (Kel)

    Time frame: 29 days (SAD), 57 days (MAD)

  8. Pharmacokinetics of PRS-220 - Serum concentrations (t1/2)

    \- Terminal elimination half-life (t1/2)

    Time frame: 29 days (SAD), 57 days (MAD)

  9. Pharmacokinetics of PRS-220 - Serum concentrations (MRT)

    \- Mean residence time (MRT)

    Time frame: 29 days (SAD), 57 days (MAD)

  10. Immunogenicity - Anti-drug antibodies (ADA)

    Immunogenicity potential of PRS-220 will be assessed by the presence and titer of anti-drug antibodies (ADA) in the serum.

    Time frame: 29 days (SAD), 57 days (MAD)

07

Study locations

1 site
  • Nucleus Network Pty Ltd.
    Melbourne, Victoria 3004, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2022 to primary completion in Aug 2023, 9 months.

Of 58 industry-sponsored phase 1 interventional studies under Idiopathic Pulmonary Fibrosis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's 9 months is close to that.

Counting every sponsor, half of 73 studies reached it within 12 months; a quarter within 5 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2022
First posted
Jul 26, 2022
StartActual
Oct 31, 2022
Primary completionActual
Aug 11, 2023
CompletionActual
Aug 11, 2023
Last update
Oct 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05473533
Lead sponsor
Pieris Australia Pty Ltd
Responsible party
Sponsor
First posted
Jul 26, 2022
Start date
Oct 31, 2022
Primary completion
Aug 11, 2023
Completion
Aug 11, 2023
Last update
Oct 23, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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