Trials / Recruiting
RecruitingNCT06016088
A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- Sponsor
- Respirion Pharmaceuticals Pty Ltd · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DRUG | Tobramycin inhalation solution | Tobramycin inhalation solution is 300 mg tobramycin in 5 mL solution. |
Timeline
- Start date
- 2024-04-01
- Primary completion
- 2026-04-01
- Completion
- 2026-06-01
- First posted
- 2023-08-29
- Last updated
- 2025-12-29
Locations
22 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06016088. Inclusion in this directory is not an endorsement.