Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
9 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal