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Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

Primary Purpose

Peanut Allergy, Immunotherapy, Pharmacokinetics

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

sublingual film with peanut extract

About this trial

This is an interventional other trial for Peanut Allergy

Eligibility Criteria

3 Years - 30 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sublingual film with peanut extract

Arm Description

Outcomes

Primary Outcome Measures

Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement

Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement

Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement

Secondary Outcome Measures

Full Information

NCT ID

NCT03070561

First Posted

February 28, 2017

Last Updated

February 28, 2017

Sponsor

Johns Hopkins University

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT03070561

Brief Title

Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

January 14, 2014 (Actual)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Allergy, Immunotherapy, Pharmacokinetics

7. Study Design

Primary Purpose

Other

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Open label, crossover, local pharmacokinetics study

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sublingual film with peanut extract

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

sublingual film with peanut extract

Primary Outcome Measure Information:

Title

Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement

Time Frame

3 days

Title

Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement

Time Frame

3 days

Title

Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement

Time Frame

3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Corinne Keet, MD, PhD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

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