Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AL-53817 · 1 trial · 2 indications
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...
AL-53817 is an investigational small molecule being developed by Alcon Inc. for the treatment of allergic conjunctivitis and nasal allergies. It has been studied as a nasal spray solution for nasal allergies and as an ophthalmic solution for allergic conjunctivitis. The drug is still in clinical development and is not approved.
AL-53817 is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker ALC. Alcon has conducted clinical trials of AL-53817 for allergic conjunctivitis and nasal allergies.
AL-53817 has completed Phase 1 and Phase 2 clinical trials. A Phase 1 trial of the nasal spray solution for nasal allergies was completed, and a Phase 2 trial of the ophthalmic solution for allergic conjunctivitis was also completed. The drug remains investigational.
AL-53817 has been studied in two completed trials. NCT01454505 was a Phase 1 safety and efficacy study of AL-53817 nasal spray solution for nasal allergies with 110 participants. NCT02079649 was a Phase 2 study of AL-53817 and AL-78843 ophthalmic solutions for allergic conjunctivitis with 224 participants.
No, AL-53817 and AL-78843 are different investigational drugs. They were studied together in a Phase 2 clinical trial (NCT02079649) that evaluated both ophthalmic solutions for the treatment of allergic conjunctivitis, but they are separate compounds.