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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
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.
Secondary ID [1] 0 0
PRS-220-PCS_11_21
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety & tolerability - AEs
Timepoint [1] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [2] 0 0
Safety & tolerability - SAEs
Timepoint [2] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [3] 0 0
Safety & tolerability - TEAEs
Timepoint [3] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [4] 0 0
Safety & tolerability - Vital signs (change in blood pressure)
Timepoint [4] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [5] 0 0
Safety & tolerability - Vital signs (change in heart rate)
Timepoint [5] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [6] 0 0
Safety & tolerability - Vital signs (change in body temperature)
Timepoint [6] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [7] 0 0
Safety & tolerability - Vital signs (change in respiratory rate)
Timepoint [7] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [8] 0 0
Safety & tolerability - Vital signs (change in oxygen saturation)
Timepoint [8] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [9] 0 0
Safety & tolerability - 12-lead ECGs
Timepoint [9] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [10] 0 0
Safety & tolerability - Spirometry (FEV1)
Timepoint [10] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [11] 0 0
Safety & tolerability - Spirometry (PEFR)
Timepoint [11] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [12] 0 0
Safety & tolerability - Spirometry (FVC)
Timepoint [12] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [13] 0 0
Safety & tolerability - Serum chemistry (sodium)
Timepoint [13] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [14] 0 0
Safety & tolerability - Serum chemistry (potassium)
Timepoint [14] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [15] 0 0
Safety & tolerability - Serum chemistry (chloride)
Timepoint [15] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [16] 0 0
Safety & tolerability - Serum chemistry (calcium)
Timepoint [16] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [17] 0 0
Safety & tolerability - Serum chemistry (magnesium)
Timepoint [17] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [18] 0 0
Safety & tolerability - Serum chemistry (bicarbonate)
Timepoint [18] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [19] 0 0
Safety & tolerability - Serum chemistry (urea/urea nitrogen)
Timepoint [19] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [20] 0 0
Safety & tolerability - Serum chemistry (creatinine)
Timepoint [20] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [21] 0 0
Safety & tolerability - Serum chemistry (albumin)
Timepoint [21] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [22] 0 0
Safety & tolerability - Serum chemistry (bilirubin)
Timepoint [22] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [23] 0 0
Safety & tolerability - Serum chemistry (uric acid)
Timepoint [23] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [24] 0 0
Safety & tolerability - Serum chemistry (creatine kinase)
Timepoint [24] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [25] 0 0
Safety & tolerability - Serum chemistry (lactate dehydrogenase)
Timepoint [25] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [26] 0 0
Safety & tolerability - Hematology (hematocrit)
Timepoint [26] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [27] 0 0
Safety & tolerability - Hematology (red blood cell count)
Timepoint [27] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [28] 0 0
Safety & tolerability - Hematology (platelet count)
Timepoint [28] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [29] 0 0
Safety & tolerability - Hematology (white blood cell count)
Timepoint [29] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [30] 0 0
Safety & tolerability - Hematology (neutrophil percentage)
Timepoint [30] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [31] 0 0
Safety & tolerability - Hematology (lymphocyte percentage)
Timepoint [31] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [32] 0 0
Safety & tolerability - Hematology (eosinophil percentage)
Timepoint [32] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [33] 0 0
Safety & tolerability - Hematology (basophil percentage)
Timepoint [33] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [34] 0 0
Safety & tolerability - Hematology (monocyte percentage)
Timepoint [34] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [35] 0 0
Safety & tolerability - Urinalysis (turbidity)
Timepoint [35] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [36] 0 0
Safety & tolerability - Urinalysis (specific gravity)
Timepoint [36] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [37] 0 0
Safety & tolerability - Urinalysis (pH)
Timepoint [37] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [38] 0 0
Safety & tolerability - Urinalysis (protein)
Timepoint [38] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [39] 0 0
Safety & tolerability - Urinalysis (glucose)
Timepoint [39] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [40] 0 0
Safety & tolerability - Urinalysis (ketone)
Timepoint [40] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [41] 0 0
Safety & tolerability - Urinalysis (blood)
Timepoint [41] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [42] 0 0
Safety & tolerability - Urinalysis (nitrite)
Timepoint [42] 0 0
29 days (SAD), 57 days (MAD)
Primary outcome [43] 0 0
Tolerability - Taste characteristics
Timepoint [43] 0 0
Once after first dose on Day 1 (SAD, MAD) and again on Day 15 (MAD)
Secondary outcome [1] 0 0
Pharmacokinetics of PRS-220 - Serum concentrations (AUC0-t)
Timepoint [1] 0 0
29 days (SAD), 57 days (MAD)
Secondary outcome [2] 0 0
Pharmacokinetics of PRS-220 - Serum concentrations (AUC0-inf)
Timepoint [2] 0 0
29 days (SAD), 57 days (MAD)
Secondary outcome [3] 0 0
Pharmacokinetics of PRS-220 - Serum concentrations (AUC0-tau)
Timepoint [3] 0 0
29 days (SAD), 57 days (MAD)
Secondary outcome [4] 0 0
Pharmacokinetics of PRS-220 - Serum concentrations (AR)
Timepoint [4] 0 0
29 days (SAD), 57 days (MAD)
Secondary outcome [5] 0 0
Pharmacokinetics of PRS-220 - Serum concentrations (Cmax)
Timepoint [5] 0 0
29 days (SAD), 57 days (MAD)
Secondary outcome [6] 0 0
Pharmacokinetics of PRS-220 - Serum concentrations (Tmax)
Timepoint [6] 0 0
29 days (SAD), 57 days (MAD)
Secondary outcome [7] 0 0
Pharmacokinetics of PRS-220 - Serum concentrations (Kel)
Timepoint [7] 0 0
29 days (SAD), 57 days (MAD)
Secondary outcome [8] 0 0
Pharmacokinetics of PRS-220 - Serum concentrations (t1/2)
Timepoint [8] 0 0
29 days (SAD), 57 days (MAD)
Secondary outcome [9] 0 0
Pharmacokinetics of PRS-220 - Serum concentrations (MRT)
Timepoint [9] 0 0
29 days (SAD), 57 days (MAD)
Secondary outcome [10] 0 0
Immunogenicity - Anti-drug antibodies (ADA)
Timepoint [10] 0 0
29 days (SAD), 57 days (MAD)

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.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/08/2023
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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