This is a phase 1, multi-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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Hudson-Essex Allergy
Belleville, New Jersey, United States
Weiss Medical
Riverdale, New Jersey, United States
To evaluate the safety of INT301 compared to placebo in adult peanut allergic participants as measured by dose escalation during study.
Percentage of participants able to consistently tolerate the protocol-specified highest dose; Incidence of systemic and non-systemic adverse reactions.
Time frame: Forty-eight weeks
To evaluate pharmacologic requirements as interventions for peanut allergic participants experiencing adverse events on INT301.
Number of participants requiring treatment for systemic reactions related to experimental treatment or placebo; Number of adverse events requiring treatment for systemic reactions related to experimental treatment or placebo; Adherence to study treatment.
Time frame: Forty-eight weeks
To determine the maximally tolerated dose during the up-dosing phase for adults.
Dose amount tolerated without AEs requiring discontinuation for each participant.
Time frame: Twenty-six weeks
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