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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00777296 | Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) | PHASE1 | COMPLETED | 66 | — | — | Feb 22, 2007 | Feb 27, 2008 | Jul 30, 2020 | 11 | Belgium, Hungary +5 |
Changes in chemistry and hematology lab tests (clinically significant value of CTCAE grade ≥ 3).
| Arm | Type | Description |
|---|---|---|
| Cohort 1 - 280 mg ARIKACE™ | EXPERIMENTAL | Subjects in this cohort will receive 280 mg of ARIKACE™ |
| Cohort 1 - Placebo | PLACEBO_COMPARATOR | Subjects in this arm of cohort 1 will receive matching placebo |
| Cohort 2 - 560 mg ARIKACE™ | EXPERIMENTAL | Subjects in this cohort will receive 560 mg of ARIKACE™ |
| Cohort 2 - Placebo | PLACEBO_COMPARATOR | Subjects in this arm of cohort 2 will receive matching placebo |
| Name | Type | Description |
|---|---|---|
| ARIKACE™ | DRUG | Study start date is before Jan 18, 2017. |
| Placebo | DRUG | Study start date is before Jan 18, 2017. |
Inclusion Criteria: * Written informed consent obtained from patient or designated legal guardian prior to the performance of any study related procedures. * Male or female study subjects ≥6 years of age or older * Confirmed diagnosis of CF * History of chronic infection with P. aeruginosa * Study ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 9 | PHASE3 | VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA, VNZ/TEZ/D-IVA, VX-522 mRNA therapy |
| Sionna Therapeutics, Inc. | SION | 2 | PHASE2 | SION-719, SION-451, SION-2222, SION-109 |
| BiomX Ltd | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Illumina, Inc. | ILMN | 1 | — | Undisclosed |