Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

Early Phase 1

Completed

• Conditions: Peanut Allergy; Pharmacokinetics; Immunotherapy
• Interventions: Biological: sublingual film with peanut extract

• Registration Number: NCT03070561
• Lead Sponsor: Johns Hopkins University

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 Timeline

• Study Start: 2014-01-14
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-02
• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-02-28
• Last Update Submitted: 2017-02-28
• Study First Posted: 2017-03-03
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sublingual film with peanut extract	sublingual film with peanut extract	-

Primary Outcome Measures

Name	Time	Method
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 sublingual placement	3 days
Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement	3 days

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States