NCT03070561

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

February 28, 2017

Last Update Submit

February 28, 2017

Conditions

Peanut AllergyImmunotherapyPharmacokinetics

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Sublingual film with peanut extract

EXPERIMENTAL
Biological: sublingual film with peanut extract

Interventions

sublingual film with peanut extractBIOLOGICAL
Sublingual film with peanut extract

Eligibility Criteria

Age3 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Corinne Keet, MD, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Open label, crossover, local pharmacokinetics study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 3, 2017

Study Start

January 14, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)