Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

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Johns Hopkins University

Status and phase

Completed
Early Phase 1

Conditions

Peanut Allergy
Immunotherapy
Pharmacokinetics

Treatments

Biological: sublingual film with peanut extract

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03070561
JHU NA_00072576

Details and patient eligibility

About

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

Full 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.

Enrollment

9 patients

Sex

All

Ages

3 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Sublingual film with peanut extract
Experimental group
Treatment:
Biological: sublingual film with peanut extract

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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