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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04696822 | Bioavailability of Nasal Epinephrine | PHASE1 | COMPLETED | 12 | — | — | Nov 1, 2020 | Sep 28, 2021 | Jan 5, 2024 | 1 | Israel |
pharmacokinetic analysis
pharmacokinetic analysis
pharmacokinetic analysis
pharmacokinetic analysis
| Arm | Type | Description |
|---|---|---|
| Adults with seasonal allergic rhinitis | EXPERIMENTAL | Single administration of 1.6mg or 3.2 mg Epinephrine powder nasal spray, with or without allergenic challenge, and single IM 0.3 mg Epinephrine without allergenic challenge. |
| Name | Type | Description |
|---|---|---|
| Epinephrine Nasal Product, 1.6 mg | DRUG | Single dose Nasal powder spray without allergen challenge |
| Epinephrine nasal product, 1.6 mg + allergen | DRUG | Single dose Nasal powder spray with allergen challenge |
| Epinephrine Injection 0.3 mg | DRUG | Intramuscular injection |
| Epinephrine Nasal Product, 3.2 mg | DRUG | Twice dose Nasal powder spray without allergen challenge |
| Epinephrine Nasal Product, 3.2 mg + allergen | DRUG | Twice dose Nasal powder spray with allergen challenge |
Inclusion Criteria: The following inclusion criteria will be assessed at screening (within 28 days prior to the first drug administration): 1. Non-smoking, male and female subjects from 18 to 55 years of age. 2. Documented Positive skin allergy test during the last year. 3. History of hay fever, s...