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

PHASE1PHASE2RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-04-01

Primary completion: 2025-04-01

Study completion finish: 2025-04-01

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT06016088

Intervention or treatment

DRUG: RSP-1502

DRUG: Tobramycin inhalation solution

Conditions

• Cystic Fibrosis Lung
• Respiratory Infections, Recurrent, Chronic
• Pseudomonas Aeruginosa

Condition: Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic and more
DRUG: RSP-1502 and other drugs
Westmead, New South Wales, Australia and more
Sponsor: Respirion Pharmaceuticals Pty Ltd

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Find a site

Closest Location:

Westmead Hospital

Research sites nearby

Select from list below to view details:

Westmead Hospital
Westmead, New South Wales, 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

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?

Participant Group/Arm	Intervention/Treatment
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.
ACTIVE_COMPARATOR: Active Control • Tobramycin Inhalation Solution 300 mg.	DRUG: Tobramycin inhalation solution Tobramycin inhalation solution is 300 mg tobramycin in 5 mL solution.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Treatment-emergent adverse events	Not Specified	Day 1 through Day 28
Treatment-emergent serious adverse events	Not Specified	Day 1 through Day 28
Changes in post-dose spirometry	Forced expiratory volume in 1 second	Day 1, Day 2, and Day 14
Pulmonary exacerbations	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	PR interval, QRS interval, QT interval	Day 1 and Day 2

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Pharmacokinetic parameters for CaEDTA	Not Specified	Day 1
Pharmacokinetic parameters for tobramycin	Not Specified	Day 1

Frequently Asked Questions

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References

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