Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03070561
• Other study ID #: JHU NA_00072576
• Status: Completed
• Phase: Early Phase 1
• First received: February 28, 2017
• Last updated: February 28, 2017
• Start date: January 14, 2014
• Est. completion date: May 2015

Study information

• Verified date: February 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Immunotherapy
• Peanut Allergy
• Peanut Hypersensitivity
• Pharmacokinetics

Intervention

Biological:
• sublingual film with peanut extract

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement		3 days
Primary	Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement		3 days
Primary	Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement		3 days