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Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03070561
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Johns Hopkins University

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

Condition or disease Intervention/treatment Phase
Peanut Allergy Immunotherapy Pharmacokinetics Biological: sublingual film with peanut extract Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label, crossover, local pharmacokinetics study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluating the Placement of a Peanut Immunotherapy Dissolving Film in Healthy Subjects
Actual Study Start Date : January 14, 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sublingual film with peanut extract Biological: sublingual film with peanut extract



Primary Outcome Measures :
  1. Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement [ Time Frame: 3 days ]
  2. Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement [ Time Frame: 3 days ]
  3. Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement [ Time Frame: 3 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070561


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Corinne Keet, MD, PhD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03070561    
Other Study ID Numbers: JHU NA_00072576
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases