Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06238856 | Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas Aeruginosa | PHASE1 | COMPLETED | 18 | — | — | May 12, 2004 | Feb 8, 2005 | Feb 2, 2024 | - | — |
Safety and tolerability of three active doses of nebulized amikacin in a SLIT™ formulation.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Amikacin Dose 1 + Placebo | EXPERIMENTAL | Participants will receive a single dose of SLIT™ amikacin at Dose 1 or matching placebo by inhalation on Day 0. |
| Cohort 2: Amikacin Dose 2 + Placebo | EXPERIMENTAL | Participants will receive a single dose of SLIT™ amikacin at Dose 2 or matching placebo by inhalation on Day 0 upon initiation of Cohort 2. |
| Cohort 3: Amikacin Dose 3 + Placebo | EXPERIMENTAL | Participants will receive a single dose of SLIT™ amikacin at Dose 3 or matching placebo by inhalation on Day 0 upon initiation of Cohort 3. |
| Name | Type | Description |
|---|---|---|
| SLIT™ Amikacin | DRUG | Amikacin administered via the Pari LC STAR™ nebulizer. |
| Placebo | DRUG | Nebulized saline. |
Inclusion Criteria: * Study participants must produce sputum that is positive for Pseudomonas aeruginosa. * Confirmed diagnosis of CF (positive sweat chloride \>60 milliequivalents (mEq)/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accomp...
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|---|---|---|---|---|
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