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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Respirion Pharmaceuticals Pty Ltd
Study ID
NCT06016088
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RSP-1502 — DRUG
    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 — DRUG
    Tobramycin inhalation solution is 300 mg tobramycin in 5 mL solution.

Study Details

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

Key Dates

Start date
Apr 1, 2024
Status verified
Dec 2025
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Active Control
    • Tobramycin Inhalation Solution 300 mg.

Primary Outcome Measure

Treatment-emergent adverse events [ Time Frame: Day 1 through Day 28 ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Tucson Cystic Fibrosis CenterTucsonArizona85750
Elizabeth Ryan
[email protected]
Cori Daines, MD (PRINCIPAL_INVESTIGATOR)
Center for Cystic Fibrosis at Keck Medical Center of USCLos AngelesCalifornia90033
Lynn Fukushima
[email protected]
Adupa Rao, MD (PRINCIPAL_INVESTIGATOR)
Stanford University Medical CenterPalo AltoCalifornia94305
Lani Demchak
[email protected]
Carlos Milla, MD (PRINCIPAL_INVESTIGATOR)
Augusta UniversityAugustaGeorgia30912
Caralee Forseen, MD (PRINCIPAL_INVESTIGATOR)
The Cystic Fibrosis InstituteNorthfieldIllinois60093
Karolina Roszko
[email protected]
Steven Boas, MD (PRINCIPAL_INVESTIGATOR)
Tulane UniversityNew OrleansLouisiana70118
Shae Williams
[email protected]
Ross Klingsberg, MD (PRINCIPAL_INVESTIGATOR)
The Minnesota Cystic Fibrosis CenterMinneapolisMinnesota55403
Kathleen Mahan, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63130
Daniel Rosenbluth, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Cystic Fibrosis ProgramNew YorkNew York10027
Cayla Boodram
[email protected]
Claire Keating, MD (PRINCIPAL_INVESTIGATOR)
Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical CenterClevelandOhio44106
Cindy Schaefer
[email protected]
Alex Gifford, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Terri Johnson
[email protected]
Karen McCoy, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Kishan Patel
[email protected]
Daniel Dorgan, MD (PRINCIPAL_INVESTIGATOR)
Dell Children's Medical Center of Central TexasAustinTexas78723
Kristina Adrean
[email protected]
Jason Fullmer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tucson, AZ

By research site
Tucson Cystic Fibrosis Center· Tucson, AZCenter for Cystic Fibrosis at Keck Medical Center of USC· Los Angeles, CAStanford University Medical Center· Palo Alto, CAAugusta University· Augusta, GAThe Cystic Fibrosis Institute· Northfield, ILTulane University· New Orleans, LA

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