Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

Status Completed

Clinical Trial Summary

Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03070561
Study type	Interventional
Source	Johns Hopkins University
Contact
Status	Completed
Phase	Early Phase 1
Start date	January 14, 2014
Completion date	May 2015

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