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A Phase 1 Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut.

Study Purpose

This is a phase 1, single-center, randomized, double-blind, placebo-controlled study in adult participants with peanut allergy. Participants will be randomized in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. The treatment group will be blinded to the investigator, participants, and the Intrommune study team.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

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 >.
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

Trial Details

Trial ID:

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.

NCT04603300
Phase

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.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Intrommune Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy
Arms & Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Hudson-Essex Allergy, Belleville, New Jersey

Status

Recruiting

Address

Hudson-Essex Allergy

Belleville, New Jersey, 07109

Site Contact

Jose Flores

jflores@circuitclinical.com

201-320-7677

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