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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01454505 | Safety and Efficacy of AL-53817 Nasal Spray Solution | PHASE1 | COMPLETED | 110 | — | — | Oct 1, 2011 | Mar 1, 2012 | May 20, 2013 | 1 | United States |
Adverse events, including serious adverse events and deaths, were reported regardless of test article relationship.
Stage B: Nasal congestion was assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. Nasal congestion was scored on a scale from 0-3, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.
| Arm | Type | Description |
|---|---|---|
| Stage B/AL-53817 | EXPERIMENTAL | Stage B: AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC. |
| Stage B/Vehicle | PLACEBO_COMPARATOR | Stage B: Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC. |
| Name | Type | Description |
|---|---|---|
| AL-53817 nasal spray solution | DRUG | Active ingredients administered in 1 of 3 concentrations during Stage A to determine maximum tolerated dose (MTD), and administered at maximum tolerated dose during Stage B. |
| Vehicle nasal spray | OTHER | Inactive ingredients used as placebo comparator during Stage A and Stage B. |
Stage A Inclusion Criteria: * Willing and able to give written informed consent. * In good health in the opinion of an appropriately qualified physician. * Females of childbearing potential (who are not at least 1 year post-menopausal or surgically sterilized) must have a negative urine pregnancy t...