Conditions: Peanut Allergy
Keywords: Food Allergy Peanut Sublingual Immunotherapy
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 5
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine if a new method of administration of peanut sublingual immunotherapy, a dissolving peanut film, is effective.

Detailed description:
Peanut allergy is a common problem with no current treatment. Recent studies have shown some success with oral or sublingual immunotherapy for the treatment of food allergy. Oral treatment, which requires very high doses, is associated with a small but appreciable risk of systemic reactions. Sublingual immunotherapy, which utilizes much smaller doses, is safer but constraints inherent in the available methods of sublingual administration have limited the utility of this method. Typically sublingual immunotherapy for food allergy has used either fresh foods or a simple liquid extract. These methods are not optimized for practicality or dwell duration in the mouth, and, thus far, dosing has been limited by the ability to make concentrated extracts and by the volume of extract that can be applied to the sublingual space. This study is being conducted to determine if a dissolving peanut extract film, will improve efficacy for immunotherapy for peanut allergy.

Arms:
arm 1: Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film. arm 2: Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films.

Interventions: intervention 1: Peanut Dissolving Film
Intervention descriptions: intervention 1: None

Protocol document: