NCT03070561

Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

Evaluating the Placement of a Peanut Immunotherapy Dissolving Film in Healthy Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 3 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Peanut Allergy
• Immunotherapy
• Pharmacokinetics

Interventions

Type	Name	Description
BIOLOGICAL	sublingual film with peanut extract

Timeline

• Start date: 2014-01-14
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2017-03-03
• Last updated: 2017-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study