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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05010577 | Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection | PHASE1 | COMPLETED | 43 | — | — | Jun 21, 2022 | Mar 10, 2024 | Jul 18, 2025 | 28 | United States, Czechia +3 |
Incidence of treatment emergent adverse events following single and multiple doses of BX004-A administered by inhalation
| Arm | Type | Description |
|---|---|---|
| BX004-A | EXPERIMENTAL | Participants will be randomized to receive standard dose of nebulized bacteriophage |
| Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive nebulized placebo |
| Name | Type | Description |
|---|---|---|
| BX004-A | DRUG | Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa |
| Placebo | DRUG | Nebulized placebo |
Key Inclusion Criteria: * Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications * Age ≥ 18 years * FEV1 ≥ 40% predicted * Clinically stable lung disease * Willing and able to provide adequate sputum samples, using any method (spon...