Evaluating the Placement of a Peanut Immunotherapy Dissolving Film in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Sublingual film with peanut extract
Intervention: sublingual film with peanut extract (Biological)
Outcomes
Primary Outcomes
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 sublingual placement
Time Frame: 3 days
Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement
Time Frame: 3 days
Secondary Outcomes
No secondary outcomes reported