An Early Phase 1 interventional study of sublingual film with peanut extract in Peanut Allergy, Immunotherapy and Pharmacokinetics, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 3 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by Johns Hopkins University · Early Phase 1, Interventional, and Other
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.
152 studies on the registry are indexed under Peanut Hypersensitivity; 29 are open to participants now.
This study's enrollment of 9 is below the median of 50 across 117 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: sublingual film with peanut extract
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
Plan to share: No
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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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