Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics; Peanut Allergy; Immunotherapy
• Intervention / Treatment: Biological: sublingual film with peanut extract

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 30 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sublingual film with peanut extract	Biological: sublingual film with peanut extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 buccal placement	3 days
Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement	3 days

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Corinne Keet, MD, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2014
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (ACTUAL): March 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nut and Peanut Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: JHU NA_00072576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No