Clinical Trial Finder

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 >0.35 kU/L.

• - 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).

Exclusion Criteria:

• - 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.

• - 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.

- Current pregnancy or lactating

Arms

Active Comparator: Active treatment

INT301 dosing as determined by cohort assignment

Placebo Comparator: Placebo

Placebo as determined by cohort assignment

Interventions

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