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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 64 Years
Gender All
More Inclusion & Exclusion Criteria

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:

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05473533
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pieris Australia Pty Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Healthy
Additional Details

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.

Arms & Interventions

Arms

Placebo Comparator: Arm 1

Placebo

Experimental: Arm 2

PRS-220

Interventions

Drug: - Placebo

Placebo; formulated as solution for inhalation without active substance.

Drug: - PRS-220

PRS-220; formulated as solution for inhalation.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nucleus Network Pty Ltd., Melbourne, Victoria, Australia

Status

Recruiting

Address

Nucleus Network Pty Ltd.

Melbourne, Victoria, 3004

Site Contact

Philip Ryan, Dr

reply@nucleusnetwork.com.au

+61 385939859