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Completed

NCT Number: NCT03070561

Evaluating 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

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Key information

Conditions

Peanut Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunotherapy Nut and Peanut Hypersensitivity Peanut Hypersensitivity Pharmacokinetics

Age range

3 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sublingual film with peanut extract

Biological

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 3, 2017
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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