Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

Completed · Early Phase 1

Conditions studied: Peanut Allergy, Immunotherapy, Pharmacokinetics

In brief

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

Key facts

Study ID

NCT03070561

Run by

Johns Hopkins University

People needed

9

Starts

2014-01-14

Expected to finish

2015-05-01

Last updated by the study team

2017-03-03

Who can join

Age: 3 and older, up to 30. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• History of reaction to peanuts
• Major active medical problems of the oral cavity or use of medications that might change rates of salivation

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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