Immunotherapy, Peanut Allergy, Pharmacokinetics
Conditions
Brief summary
Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children
Detailed description
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.
Interventions
BIOLOGICALsublingual film with peanut extract
Sponsors
National Institutes of Health (NIH)
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open label, crossover, local pharmacokinetics study
Eligibility
Sex/Gender
ALL
Age
3 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement | 3 days |
| Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement | 3 days |
| Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement | 3 days |
Countries
United States
Outcome results
None listed