Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

Early Phase 1CompletedNCT03070561

Johns Hopkins University9 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Peanut Allergy Immunotherapy Pharmacokinetics

Interventions

sublingual film with peanut extractBIOLOGICAL

Eligibility

Sex: ALLMin age: 3 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 Exclusion Criteria: * History of reaction to peanuts * Major active medical problems of the oral cavity or use of medications that might change rates of salivation

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement

Time frame: 3 days

Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement

Time frame: 3 days

Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement

Time frame: 3 days

Data from ClinicalTrials.gov

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