Trials / Completed
CompletedNCT06238856
Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas Aeruginosa
Safety and Tolerability Study of Single Dose Escalations of TR02 (SLIT™ Amikacin) by Inhalation in Cystic Fibrosis Study Patients With Chronic Infections of Pseudomonas Aeruginosa
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Insmed Incorporated · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to evaluate the safety and tolerability of three active doses of nebulized amikacin in a SLIT™ formulation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SLIT™ Amikacin | Amikacin administered via the Pari LC STAR™ nebulizer. |
| DRUG | Placebo | Nebulized saline. |
Timeline
- Start date
- 2004-05-12
- Primary completion
- 2005-02-08
- Completion
- 2005-02-08
- First posted
- 2024-02-02
- Last updated
- 2024-02-02
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06238856. Inclusion in this directory is not an endorsement.