Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 55 Years|
Inclusion Criteria:Participant must be 18-55 years of age inclusive, at the time of signing the informed consent. Female participants of childbearing potential or male participants with female partners of child-bearing potential must utilize highly effective birth control method(s) throughout the study and for 30 days after the final dose of study drug. Acceptable methods of contraception include: complete abstinence, male or female condoms with spermicide, oral or implanted contraceptives, or vasectomy. For female participants of child-bearing potential: Negative serum beta human chorionic gonadotrophin (HCG) pregnancy test at screening. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Meets at least one of the following conditions
- - Positive skin prick test (SPT) (wheal at least 3 mm greater than control) AND/OR Peanut specific IgE >.
- - Convincing clinical history of allergic reaction to peanut within 1 hour of ingestion for at least 3 months prior to screening.
- - Failed an oral food challenge (OFC) of < 100mg of peanut protein at screening.
- - Participant willing and able to undergo the procedures required by the protocol, including, assessment completion, protocol compliance, and participation in the placebo dosing period(s).
- - History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or oxygen saturations < 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence) - Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would make the subject unsuitable for induction of food reactions - Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease - Psychiatric disorders that the Investigator believes will interfere with study assessments - Known glycerin allergy - Uncontrolled asthma, defined by at least one of the following conditions: - - FEV1 <80% of predicted, or ratio of FEV1 to forced vital capacity (FEV1/FVC) <75% of predicted, with or without controller medications.
- - - Inhaled corticosteroids (ICS) dosing of >500mcg daily fluticasone (or equivalent ICS based on NHLBI dosing chart.
- - - One hospitalization in the past year for asthma - - An ER visit for asthma within six months prior to screening - Planned dental surgery during from screening until study exit - Moderate or advanced periodontal disease.
- - Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within 1 year prior to screening.
- - Currently in a build-up phase of any allergen immunotherapy - Use of oral beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers within 2 weeks prior to screening.
- - Inability to discontinue oral or nasal antihistamines, antihistamine eye drops, intranasal or oral steroids from 2 weeks prior to baseline procedures to post completion of visit 8.
- - Use tricyclic antidepressants and monoamine oxidase inhibitors within 3 months prior to screening.
- - Current pregnancy or lactating - Participating in any interventional study for the treatment of food allergy in the past 6 months prior to screening.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
Active Comparator: Active treatment
INT301 dosing as determined by cohort assignment
Placebo Comparator: Placebo
Placebo as determined by cohort assignment
Drug: - INT301
INT301 is an allergy immunotherapy delivered in the form of a fully functional toothpaste
Drug: - Placebo
Fully functional toothpaste containing no immunotherapy agents
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Erick B Berglund, PhD
For additional contact information, you can also visit the trial on clinicaltrials.gov.