A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection

December 24, 2025 updated by: Respirion Pharmaceuticals Pty Ltd

A Double-Blind, Active-Controlled, Multiple-Ascending Dose, Phase 1b/2a Study of Aerosolized RSP-1502 Delivered Via the PARI LC Plus® Nebulizer in Subjects With Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection

A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This dose escalation safety study will evaluate several doses of RSP-1502 or active control administered by inhalation for 14 days. Following determination of the MTD, a dose expansion cohort will receive RSP-1502 at the MTD versus active control administered by inhalation for 14 days. All subjects will be followed for 14 days after completion of dosing.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
    • Queensland
    • South Australia
      • Adelaide, South Australia, Australia
    • Victoria
    • Western Australia
      • Nedlands, Western Australia, Australia
      • Perth, Western Australia, Australia
        • Recruiting
        • The Kids Research Institute Australia, Perth Children's Hospital
        • Contact:
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85750
        • Recruiting
        • Tucson Cystic Fibrosis Center
        • Principal Investigator:
          • Cori Daines, MD
        • Contact:
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Center for Cystic Fibrosis at Keck Medical Center of USC
        • Contact:
        • Principal Investigator:
          • Adupa Rao, MD
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford University Medical Center
        • Principal Investigator:
          • Carlos Milla, MD
        • Contact:
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University
        • Principal Investigator:
          • Caralee Forseen, MD
        • Contact:
    • Illinois
      • Northfield, Illinois, United States, 60093
        • Recruiting
        • The Cystic Fibrosis Institute
        • Contact:
        • Principal Investigator:
          • Steven Boas, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Recruiting
        • Tulane University
        • Principal Investigator:
          • Ross Klingsberg, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55403
        • Recruiting
        • The Minnesota Cystic Fibrosis Center
        • Principal Investigator:
          • Kathleen Mahan, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Daniel Rosenbluth, MD
        • Contact:
    • New York
      • New York, New York, United States, 10027
        • Recruiting
        • Columbia University Cystic Fibrosis Program
        • Principal Investigator:
          • Claire Keating, MD
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Alex Gifford, MD
        • Contact:
      • Columbus, Ohio, United States, 43205
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Texas
      • Austin, Texas, United States, 78723
        • Recruiting
        • Dell Children's Medical Center of Central Texas
        • Contact:
        • Principal Investigator:
          • Jason Fullmer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males or females aged ≥18 years of age for cohorts 1-4; males or females ≥12 years of age for cohort 5.
  • Diagnosis of CF based on the following: historical positive sweat chloride value ≥ 60 mEq/L, and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype.
  • History of P. aeruginosa-positive sputum cultures or throat swabs with at least 50% positive in the 2 years preceding screening.
  • P. aeruginosa-positive sputum culture at screening.
  • Forced expiratory volume in 1 second (FEV1) ≥ 30 and ≤ 120% predicted per Global Lung Function Initiative (GLI) equation, pre- or post-bronchodilator.
  • Must be able to withhold all other inhaled tobramycin from Day -28 to Day 28 of study participation. Must be able to withhold all other inhaled antibiotics from Day -14 to Day 28.
  • Medically stable with no evidence of significant new or acute respiratory symptoms within 30 days prior to screening.
  • Hematology, clinical chemistry, and urinalysis results with no clinically significant abnormalities that would interfere with the study assessments at screening as determined by the investigator.
  • Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from screening through the Day 28 visit: hormonal (oral, implant, or injection) begun > 30 days prior to screening, barrier (condom, diaphragm with spermicide), intrauterine device, or vasectomized partner (6 months minimum).
  • Male subjects must show documentation of infertility or agree to use condoms during study participation.
  • Must be able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form, and be capable and willing to complete all study visits and perform all study required procedures.

Exclusion Criteria:

  • A history of previous allergy or sensitivity to components of RSP 1502.
  • A history of intolerance to inhaled tobramycin (TOBI®, BETHKIS®, TOBI® Podhaler®, tobramycin inhalation solution).
  • eGFR < 40 mL/min, or serum total bilirubin > 2X or serum transaminases > 3X the upper limit of normal range at screening.
  • Currently taking other medications with known nephrotoxic, neurotoxic, or ototoxic potential (subjects receiving inhaled tobramycin in conjunction with low dose azithromycin prior to study participation without evidence of ototoxicity may continue taking low dose azithromycin during the study).
  • Currently taking ethacrynic acid, furosemide, urea, or intravenous mannitol.

  • Lung infection with organisms associated with a more rapid decline in pulmonary status (including, but not limited to, Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus). For subjects who have had a history of a positive culture, the investigator will apply the following criteria to establish whether the subject is free of infection with such organisms:

    1. The subject has not had a respiratory tract culture positive for these organisms within the 12 months before the date of informed consent.
    2. The subject has had at least 2 respiratory tract cultures negative for such organisms within the 12 months before the date of informed consent, with the first and last of these separated by at least 3 months, and the most recent one within the 6 months before the date of informed consent.
  • Consistent inability to produce sputum and unwillingness to perform sputum induction.
  • Any acute upper or lower respiratory tract infection or pulmonary exacerbation requiring changes in therapy (including systemic antibiotics), or other significant clinical/laboratory/radiological/spirometric sign of unstable or unexpectedly deteriorating respiratory disease within 30 days prior to the first study drug administration.
  • Initiation or adjustment of chronic airway medications (eg, inhaled corticosteroids; chronic suppressive antibacterial treatment) or airway clearance regimen (eg, nebulized saline, rhDNase, initiation of mechanical vest or handheld airway clearance device) within 28 days prior to screening. Individuals can be rescreened 28 days after these agents/therapies have been established for at least 28 days.
  • Is immunocompromised due to illness, or solid or hematological organ transplant.
  • Requires systemic prednisone (or equivalent) > 10 mg daily.
  • Vaping or smoking tobacco or any other substance within 1 month prior to screening and anticipated inability to refrain from vaping or smoking throughout the study.
  • Female subjects who are pregnant, lactating, or have a positive urine human chorionic gonadotropin (pregnancy) test, as determined by laboratory testing.
  • HIV positive.
  • Active Hepatitis B or C.
  • History of recreational drug or alcohol use/abuse which in the opinion of the investigator will compromise the patient's ability to comply with the study protocol.
  • Participation in a clinical study with administration of an investigational drug product within the previous 30 days, or five half-lives of the previously administered investigational product.
  • Has any other medical condition(s) which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject or impact the validity of the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Control
• Tobramycin Inhalation Solution 300 mg.
Drug: Tobramycin inhalation solution
Tobramycin inhalation solution is 300 mg tobramycin in 5 mL solution.
Experimental: RSP-1502

Cohorts 1-4 will receive RSP-1502 (300 mg tobramycin plus an ascending dose of CaEDTA).

Cohort 5 will receive 300 mg tobramycin + CaEDTA at the MTD.
Drug: RSP-1502
RSP-1502 is a sterile, preservative free solution to be administered by inhalation via a nebulizer. Each dose of RSP-1502 contains the active components tobramycin (300 mg) and CaEDTA in a 5 mL solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-emergent adverse events
Time Frame: Day 1 through Day 28
Day 1 through Day 28
Treatment-emergent serious adverse events
Time Frame: Day 1 through Day 28
Day 1 through Day 28
Changes in post-dose spirometry
Time Frame: Day 1, Day 2, and Day 14
Forced expiratory volume in 1 second
Day 1, Day 2, and Day 14
Pulmonary exacerbations
Time Frame: Day 1 through Day 28
A period of treatment with intravenous antibiotics in the hospital and/or at home
Day 1 through Day 28
Changes in post-dose electrocardiogram results
Time Frame: Day 1, Day 2, and Day 14
PR interval, QRS interval, QT interval
Day 1, Day 2, and Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters for CaEDTA
Time Frame: Day 1, Day 2, Day 14, and Day 28
Day 1, Day 2, Day 14, and Day 28
Pharmacokinetic parameters for tobramycin
Time Frame: Day 1, Day 2, Day 14, and Day 28
Day 1, Day 2, Day 14, and Day 28

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiology parameters
Time Frame: Day 1 to Day 14; Day 1 to Day 28
Change from baseline in Pseudomonas aeruginosa CFUs
Day 1 to Day 14; Day 1 to Day 28
Change from baseline in CFQ-R Respiratory Symptoms Score
Time Frame: Day 1 to Day 28
Day 1 to Day 28
Change from baseline in Chronic Respiratory Infection Symptom Score
Time Frame: Day 1 to Day 28
Day 1 to Day 28
Pharmacodynamic parameters
Time Frame: Day 1, Day 14, and Day 28
Biomarkers in sputum
Day 1, Day 14, and Day 28
Change from baseline in spirometry
Time Frame: Day 1 to Day 28
Forced expiratory volume in 1 second (absolute change; change in % predicted)
Day 1 to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Respirion Pharmaceuticals Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 24, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESPIR-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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