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

18 - 55
Phase 1

Brief Summary

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

ClinicalTrials.gov Identifier: NCT04603300
Recruitment Status: Recruiting
First Posted: 10/26/2020 12:00:00 AM
Last Update Posted: 8/24/2021 12:00:00 AM


Drug: Placebo / Fully functional toothpaste containing no immunotherapy agents

You may be eligible to join if...

participant must be 18-55 years of age inclusive, at the time of signing the informed

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).

You may NOT be eligible to join if...

- 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

- 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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Information may not constitute the most up-to-date trial information. Read our disclaimer for details.

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