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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06016088
Other study ID # RESPIR-102
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 1, 2024
Est. completion date April 2025

Study information

Verified date May 2024
Source Respirion Pharmaceuticals Pty Ltd
Contact Brian Jones, PhD
Phone 215-732-5452
Email bjones@respirionpharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date April 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Males or females aged =18 years of age. - 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 year preceding screening. - P. aeruginosa-positive sputum culture at screening. - Forced expiratory volume in 1 second (FEV1) = 40 and = 90% 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. 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 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. - 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 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. - Smoking or vaping tobacco or any substance within 6 months prior to screening and anticipated inability to refrain from smoking throughout the study. - Female subjects who are pregnant, lactating, or have a positive serum 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.

Study Design


Intervention

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.
Tobramycin inhalation solution
Tobramycin inhalation solution is 300 mg tobramycin in 5 mL solution.

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia The Alfred Hospital Camperdown New South Wales
Australia Lung Institute of Western Australia Nedlands Western Australia
Australia Westmead Hospital Westmead New South Wales
United States Augusta University Augusta Georgia
United States Dell Children's Medical Center of Central Texas Austin Texas
United States Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center Cleveland Ohio
United States Nationwide Children's Hospital Columbus Ohio
United States Center for Cystic Fibrosis at Keck Medical Center of USC Los Angeles California
United States The Minnesota Cystic Fibrosis Center Minneapolis Minnesota
United States Tulane University New Orleans Louisiana
United States Columbia University Cystic Fibrosis Program New York New York
United States Stanford University Medical Center Palo Alto California
United States University of Pennsylvania Philadelphia Pennsylvania
United States Washington University School of Medicine Saint Louis Missouri
United States Tucson Cystic Fibrosis Center Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Respirion Pharmaceuticals Pty Ltd

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other Pharmacodynamic parameters Biomarkers in sputum Day 1, Day 14, and Day 28
Other Microbiology parameters Change from baseline in Pseudomonas aeruginosa CFUs Day 1 to Day 14; Day 1 to Day 28
Other Change from baseline in spirometry Forced expiratory volume in 1 second (absolute change; change in % predicted) Day 1 to Day 28
Other Change from baseline in CFQ-R Respiratory Symptoms Score Day 1 to Day 28
Other Change from baseline in Chronic Respiratory Infection Symptom Score Day 1 to Day 28
Primary Treatment-emergent adverse events Day 1 through Day 28
Primary Treatment-emergent serious adverse events Day 1 through Day 28
Primary Changes in post-dose spirometry Forced expiratory volume in 1 second Day 1, Day 2, and Day 14
Primary Pulmonary exacerbations A period of treatment with intravenous antibiotics in the hospital and/or at home Day 1 through Day 28
Primary Changes in post-dose electrocardiogram results PR interval, QRS interval, QT interval Day 1 and Day 2
Secondary Pharmacokinetic parameters for CaEDTA Day 1
Secondary Pharmacokinetic parameters for tobramycin Day 1
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