Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects
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Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children
Condition or disease
Biological: sublingual film with peanut extract
Early Phase 1
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.
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Layout table for eligibility information
Ages Eligible for Study:
3 Years to 30 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
History of reaction to peanuts
Major active medical problems of the oral cavity or use of medications that might change rates of salivation