Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-14

Study Completion Date

2015-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Peanut Allergy Immunotherapy Pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label, crossover, local pharmacokinetics study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sublingual film with peanut extract

Group Type EXPERIMENTAL

sublingual film with peanut extract

Intervention Type BIOLOGICAL

Interventions

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sublingual film with peanut extract

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 3 years and \<30 years.
* Able to give informed consent.
* English speaking with no language impairment
* Regularly consume a meal sized portion (approximately 5 grams) of peanut at least twice per month during the preceding 6 months