HealthyPhase 1NCT05473533
Study of Single and Multiple Doses of PRS-220 Administered by Oral Inhalation in Healthy Subjects
A Phase 1 study testing PRS-220 in people with Healthy, run by Pieris Australia Pty Ltd at 1 site in Australia.
Trial summary
A dose escalating study of PRS-220 administered by oral inhalation in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PRS-220
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Oct 2022to 11 Aug 2023
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is able to provide written ICF prior to Screening.
- 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.
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- The subject has a body mass index (BMI) between18 and 32 kg/m2 (inclusive) at Screening.
- The subject has a forced expiratory volume in one second (FEV1) ≥80% of the predicted value at Screening.
- 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.
- The subject agrees to comply with all protocol requirements.
Who cannot join
- 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
- 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).
- 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.
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- 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).
- 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).
- The subject has any history of smoking (e.g., cigarettes, e-cigarettes/vaping, marijuana, cigars) within one month prior to Screening.
- 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).
- The subject has a history of severe allergic reaction to any component of PRS-220 including its excipients.
- 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).
- 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.
- 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.
- The subject has previously enrolled in this study.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
- Conditions
- Healthy
- Being tested
- Placebo, PRS-220
- Keywords
- Idiopathic pulmonary fibrosis (IPF), Anticalin, PRS-220, Healthy Volunteers, Pieris, CTGF
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Control
Placebo; formulated as solution for inhalation without active substance.
PRS-220Drug
Also called Active
PRS-220; formulated as solution for inhalation.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
| Arm 2 | Experimental | PRS-220 Receives: Drug: PRS-220 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Serum chemistry (sodium)
To assess changes in sodium levels (mmol/L) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Serum chemistry (potassium)
To assess changes in potassium levels (mmol/L) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Serum chemistry (chloride)
To assess changes in chloride levels (mmol/L) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Serum chemistry (calcium)
To assess changes in calcium levels (mmol/L) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Serum chemistry (magnesium)
To assess changes in magnesium levels (mmol/L) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Serum chemistry (bicarbonate)
To assess changes in bicarbonate levels (mmol/L) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Serum chemistry (urea/urea nitrogen)
To assess changes in urea/urea nitrogen (BUN) levels (mmol/L) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Serum chemistry (creatinine)
To assess changes in creatinine levels (µmol/L) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Serum chemistry (albumin)
To assess changes in albumin levels (g/L) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Serum chemistry (bilirubin)
To assess changes in bilirubin levels (µmol/L) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Serum chemistry (uric acid)
To assess changes in uric acid levels (mmol/L) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Serum chemistry (creatine kinase)
To assess changes in creatine kinase (CK) levels (U/L) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Serum chemistry (lactate dehydrogenase)
To assess changes in lactate dehydrogenase (LDH) levels (U/L) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Hematology (hematocrit)
To assess changes in hematocrit levels (%) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Hematology (red blood cell count)
To assess changes in total red blood cell (RVC) counts (10^6/µL) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Hematology (platelet count)
To assess changes in platelet counts (10^9/µL) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Hematology (white blood cell count)
To assess changes in white blood cell (WBC) counts (10^3/µL) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Hematology (neutrophil percentage)
To assess changes in neutrophil percentage (%) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Hematology (lymphocyte percentage)
To assess changes in lymphocyte percentage (%) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Hematology (eosinophil percentage)
To assess changes in eosinophil percentage (%) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Hematology (basophil percentage)
To assess changes in basophil percentage (%) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Hematology (monocyte percentage)
To assess changes in monocyte percentage (%) throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Urinalysis (turbidity)
To assess changes in turbidity of the urine sample as part of a standard urinalysis panel throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Urinalysis (pH)
To assess changes in pH of the urine sample as part of a standard urinalysis panel throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
Safety & tolerability - Urinalysis (protein)
To assess changes in protein levels of the urine sample as part of a standard urinalysis panel throughout the study.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: Once after first dose on Day 1 (SAD, MAD) and again on Day 15 (MAD)
Secondary outcomes (10)
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)
Measured: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (AUC0-inf)
- AUC from time 0 extrapolated to infinity (Day 1) (AUC0-inf)
Measured: 29 days (SAD), 57 days (MAD)
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
Measured: 29 days (SAD), 57 days (MAD)
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
Measured: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (Cmax)
- Maximum observed serum concentration (Cmax)
Measured: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (Tmax)
- Time to reach maximum observed serum concentration (Tmax)
Measured: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (Kel)
- Terminal elimination rate constant (Kel)
Measured: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (t1/2)
- Terminal elimination half-life (t1/2)
Measured: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (MRT)
- Mean residence time (MRT)
Measured: 29 days (SAD), 57 days (MAD)
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.
Measured: 29 days (SAD), 57 days (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start31 Oct 2022
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase 1, dose escalating study to assess safety, tolerability, and PK of single and multiple doses of PRS-220 administered by oral inhalation to healthy male and female subjects. This study will be conducted utilizing a blinded, randomized, dose-escalating design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 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
- NCT05473533
- Sponsor's protocol ID
- PRS-220-PCS_11_21
- Status last verified
- Nov 2022
- First submitted
- 19 Jul 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05473533
- Acronym / sponsor ID
- PRS-220-PCS_11_21
- Conditions
- Healthy
- Keywords
- Idiopathic pulmonary fibrosis (IPF), Anticalin, PRS-220, Healthy Volunteers, Pieris, CTGF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Pieris Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A dose escalating study of PRS-220 administered by oral inhalation in healthy subjects
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a phase 1, dose escalating study to assess safety, tolerability, and PK of single and multiple doses of PRS-220 administered by oral inhalation to healthy male and female subjects. This study will be conducted utilizing a blinded, randomized, dose-escalating design.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: PlaceboPlacebo |
| Arm 2 | Experimental | Drug: PRS-220PRS-220 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The subject is able to provide written ICF prior to Screening.
- 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.
- 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.
- The subject has a body mass index (BMI) between18 and 32 kg/m2 (inclusive) at Screening.
- The subject has a forced expiratory volume in one second (FEV1) ≥80% of the predicted value at Screening.
Key exclusion criteria (20 listed)
- 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:
- 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).
- 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.
- 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).
- 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).
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 |
|---|---|---|
| PlaceboAlso: ControlPlacebo; formulated as solution for inhalation without active substance. | Drug | Arm 1 |
| PRS-220Also: ActivePRS-220; formulated as solution for inhalation. | Drug | Arm 2 |
Primary outcome
Safety & tolerability - AEs
Time frame: 29 days (SAD), 57 days (MAD)
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.
Safety & tolerability - SAEs
Time frame: 29 days (SAD), 57 days (MAD)
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.
Safety & tolerability - TEAEs
Time frame: 29 days (SAD), 57 days (MAD)
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.
Safety & tolerability - Vital signs (change in blood pressure)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in blood pressure (systolic and diastolic, mm Hg) as a criterion of safety and tolerability throughout the study.
Safety & tolerability - Vital signs (change in heart rate)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in heart rate (beats per minute, BPM) as a criterion of safety and tolerability throughout the study.
Safety & tolerability - Vital signs (change in body temperature)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in body temperature (degrees Celsius) as a criterion of safety and tolerability throughout the study.
Safety & tolerability - Vital signs (change in respiratory rate)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in respiratory rate (breaths per minute) as a criterion of safety and tolerability throughout the study.
Safety & tolerability - Vital signs (change in oxygen saturation)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in oxygen saturation (sO2, %) as a criterion of safety and tolerability throughout the study.
Safety & tolerability - 12-lead ECGs
Time frame: 29 days (SAD), 57 days (MAD)
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.
Safety & tolerability - Spirometry (FEV1)
Time frame: 29 days (SAD), 57 days (MAD)
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.
Safety & tolerability - Spirometry (PEFR)
Time frame: 29 days (SAD), 57 days (MAD)
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.
Safety & tolerability - Spirometry (FVC)
Time frame: 29 days (SAD), 57 days (MAD)
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.
Safety & tolerability - Serum chemistry (sodium)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in sodium levels (mmol/L) throughout the study.
Safety & tolerability - Serum chemistry (potassium)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in potassium levels (mmol/L) throughout the study.
Safety & tolerability - Serum chemistry (chloride)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in chloride levels (mmol/L) throughout the study.
Safety & tolerability - Serum chemistry (calcium)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in calcium levels (mmol/L) throughout the study.
Safety & tolerability - Serum chemistry (magnesium)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in magnesium levels (mmol/L) throughout the study.
Safety & tolerability - Serum chemistry (bicarbonate)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in bicarbonate levels (mmol/L) throughout the study.
Safety & tolerability - Serum chemistry (urea/urea nitrogen)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in urea/urea nitrogen (BUN) levels (mmol/L) throughout the study.
Safety & tolerability - Serum chemistry (creatinine)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in creatinine levels (µmol/L) throughout the study.
Safety & tolerability - Serum chemistry (albumin)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in albumin levels (g/L) throughout the study.
Safety & tolerability - Serum chemistry (bilirubin)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in bilirubin levels (µmol/L) throughout the study.
Safety & tolerability - Serum chemistry (uric acid)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in uric acid levels (mmol/L) throughout the study.
Safety & tolerability - Serum chemistry (creatine kinase)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in creatine kinase (CK) levels (U/L) throughout the study.
Safety & tolerability - Serum chemistry (lactate dehydrogenase)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in lactate dehydrogenase (LDH) levels (U/L) throughout the study.
Safety & tolerability - Hematology (hematocrit)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in hematocrit levels (%) throughout the study.
Safety & tolerability - Hematology (red blood cell count)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in total red blood cell (RVC) counts (10^6/µL) throughout the study.
Safety & tolerability - Hematology (platelet count)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in platelet counts (10^9/µL) throughout the study.
Safety & tolerability - Hematology (white blood cell count)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in white blood cell (WBC) counts (10^3/µL) throughout the study.
Safety & tolerability - Hematology (neutrophil percentage)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in neutrophil percentage (%) throughout the study.
Safety & tolerability - Hematology (lymphocyte percentage)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in lymphocyte percentage (%) throughout the study.
Safety & tolerability - Hematology (eosinophil percentage)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in eosinophil percentage (%) throughout the study.
Safety & tolerability - Hematology (basophil percentage)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in basophil percentage (%) throughout the study.
Safety & tolerability - Hematology (monocyte percentage)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in monocyte percentage (%) throughout the study.
Safety & tolerability - Urinalysis (turbidity)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in turbidity of the urine sample as part of a standard urinalysis panel throughout the study.
Safety & tolerability - Urinalysis (specific gravity)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in specific gravity of the urine sample as part of a standard urinalysis panel throughout the study.
Safety & tolerability - Urinalysis (pH)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in pH of the urine sample as part of a standard urinalysis panel throughout the study.
Safety & tolerability - Urinalysis (protein)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in protein levels of the urine sample as part of a standard urinalysis panel throughout the study.
Safety & tolerability - Urinalysis (glucose)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in glucose levels (positive/negative) of the urine sample as part of a standard urinalysis panel throughout the study.
Safety & tolerability - Urinalysis (ketone)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in ketone levels (positive/negative) of the urine sample as part of a standard urinalysis panel throughout the study.
Safety & tolerability - Urinalysis (blood)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in blood levels (positive/negative) of the urine sample as part of a standard urinalysis panel throughout the study.
Safety & tolerability - Urinalysis (nitrite)
Time frame: 29 days (SAD), 57 days (MAD)
To assess changes in nitrite levels (positive/negative) of the urine sample as part of a standard urinalysis panel throughout the study.
Tolerability - Taste characteristics
Time frame: Once after first dose on Day 1 (SAD, MAD) and again on Day 15 (MAD)
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.
10 secondary outcomes
Pharmacokinetics of PRS-220 - Serum concentrations (AUC0-t)
Time frame: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (AUC0-inf)
Time frame: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (AUC0-tau)
Time frame: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (AR)
Time frame: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (Cmax)
Time frame: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (Tmax)
Time frame: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (Kel)
Time frame: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (t1/2)
Time frame: 29 days (SAD), 57 days (MAD)
Pharmacokinetics of PRS-220 - Serum concentrations (MRT)
Time frame: 29 days (SAD), 57 days (MAD)
Immunogenicity - Anti-drug antibodies (ADA)
Time frame: 29 days (SAD), 57 days (MAD)
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 23 Oct 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRS-220 in people with Healthy, run by Pieris Australia Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety & tolerability - AEs (time frame: 29 days (SAD), 57 days (MAD)). The study lists 43 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 23 Oct 2023.