Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DESF · 2 trials · 1 indication
Baseline Corrected Maximum Epinephrine Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 10 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 20 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 30 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 45 minutes
| Arm | Type | Description |
|---|---|---|
| Single Doses of DESF and Intramuscular Manual Injection | EXPERIMENTAL | Single dose of DESF (12 mg) administered after allergen challenge (Treatment Period 1), followed by a single dose of intramuscular (IM) manual injection (0.3 mg) without allergen challenge after a 24-hour washout period (Treatment Period 2), followed by a single dose of DESF (12 mg) without allergen challenge after a 14-day washout period from Treatment Period 1. |
| Repeat Doses of DESF and Intramuscular Manual Injection | EXPERIMENTAL | Repeat dose of DESF (24 mg \[12 mg x 2\]) administered after allergen challenge (Treatment Period 1), followed by a repeat dose of IM manual injection (0.6 mg \[0.3 mg x 2\]) without allergen challenge after a 24-hour washout period (Treatment Period 2), followed by a repeat dose of DESF (24 mg \[12 mg x 2\]) without allergen challenge after a 14-day washout period from Treatment Period 1. |
| Single Dose of DESF | EXPERIMENTAL | A single dose (12 mg) of DESF administered. |
| Name | Type | Description |
|---|---|---|
| DESF | DRUG | DESF administered in the sublingual space. |
| Epinephrine Injection | DRUG | Epinephrine manual injection administered intramuscularly according to the approved prescribing information. |
Inclusion Criteria: * Willing and able to provide written informed consent and capable of following the protocol-required guidelines. * Healthy males and females 18 through 55 years of age. * Body weight ≥50 kg for males and ≥45 kg for females. * BMI ≥18 kg/m2 to ≤32 kg/m2. * Known history of oral ...