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DESF · OASIS

Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome

Ensayo de Aquestive Therapeutics, Inc. en Reaccion alergica.

Fase

Fase 2

Estado

Completado

Participantes

36

previstos

Centros

1

Fin del objetivo primario

oct 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jul 2024.

Qué mide

Cmax (0 to 240 minutes post-dose) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroA 2-part open-label study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine administered as single and repeat doses of DESF in healthy adults with oral allergy syndrome (OAS). In both parts, subjects undergo an oromucosal allergen challenge prior to administration of DESF according to randomization into two cohorts. In Part 1, there are three treatment periods evaluating single and repeat doses of study drug, DESF after an allergen challenge (Treatment Period 1), intramuscular (IM) injection without allergen challenge (Treatment Period 2), and DESF without allergen challenge (Treatment Period 3). In Part 2, there are two treatment periods evaluating single and repeat doses of study drug, DESF after an allergen challenge (Treatment Period 1) and intramuscular (IM) injection without allergen challenge (Treatment Period 2).

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Ficha completa en ClinicalTrials.gov (NCT06527937), actualizada en sep 2025.