Evaluating Peanut Immunotherapy Dissolving Film in Health... | NCT03070561

Studies
Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

NCT03070561

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Mar 3, 2017Actual

Enrollment

9Actual

Phase

Early Phase 1

Conditions

Peanut Allergy
Immunotherapy
Pharmacokinetics

Interventions

sublingual film with peanut extract

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2014Actual

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Feb 28, 2017

First Submission Date that Met QC Criteria

Feb 28, 2017

First Posted Date

Mar 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 3, 2017Actual

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sublingual film with peanut extract	Experimental		Biological: sublingual film with peanut extract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sublingual film with peanut extract	Biological		Sublingual film with peanut extract

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement		3 days
Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement		3 days
Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement		3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Corinne Keet, MD, PhD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Hospital		Baltimore	Maryland	21287	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D021183	Peanut Hypersensitivity

Ancestor Terms

ID	Term
D000074924	Nut and Peanut Hypersensitivity
D005512	Food Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided