Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT03070561
Brief Summary:
Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children
Detailed Description:
In this study, 15 non-peanut allergic children and adults will be enrolled. At three visits, each at least a day apart, the study product (dissolving film) containing approximately 60 mcg of the major peanut allergen (Ara h 2), equivalent to approximately 1000 mcg of peanut protein, will be placed in one of three areas: the sublingual space, affixed to the buccal mucosa, and in the vestibular space. Concentrations of Ara h2 in saliva collected at several locations over several time points in the mouth will be analyzed by ELISA.
Study:
NCT03070561
Study Brief:
Protocol Section:
NCT03070561