Peanut AllergyEarly Phase 1NCT03070561
Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects
A Early Phase 1 study testing sublingual film with peanut extract in people with Peanut Allergy and Immunotherapy, run by Johns Hopkins University at 1 site in United States.
Trial summary
Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children Read more about this study
- Who is it for?
- Ages 3 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Peanut Allergy, Immunotherapy, Pharmacokinetics
- What is being tested?
- sublingual film with peanut extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2014to May 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- History of reaction to peanuts
- Major active medical problems of the oral cavity or use of medications that might change rates of salivation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Placement of a Peanut Immunotherapy Dissolving Film in Healthy Subjects
Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children
Read the 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.
- Conditions
- Peanut Allergy, Immunotherapy, Pharmacokinetics
- Being tested
- sublingual film with peanut extract
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sublingual film with peanut extractBiological
| Study group | Role | What they receive |
|---|---|---|
| Sublingual film with peanut extract | Experimental | Not described Receives: Biological: sublingual film with peanut extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement
Measured: 3 days
Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement
Measured: 3 days
Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start14 Jan 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, crossover, local pharmacokinetics study
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Corinne Keet, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070561
- Sponsor's protocol ID
- JHU NA_00072576
- Status last verified
- Feb 2017
- First submitted
- 28 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Placement of a Peanut Immunotherapy Dissolving Film in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03070561
- Acronym / sponsor ID
- JHU NA_00072576
- Conditions
- Peanut Allergy, Immunotherapy, Pharmacokinetics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 14 Jan 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, crossover, local pharmacokinetics study
| Arm | Type | Receives |
|---|---|---|
| Sublingual film with peanut extract | Experimental | Biological: sublingual film with peanut extract |
Who may qualify
- Ages
- 3 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- History of reaction to peanuts
- Major active medical problems of the oral cavity or use of medications that might change rates of salivation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sublingual film with peanut extract | Biological | Sublingual film with peanut extract |
Primary outcome
Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement
Time frame: 3 days
Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement
Time frame: 3 days
Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Keet, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing sublingual film with peanut extract in people with Peanut Allergy and Immunotherapy, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.