drugset / Trial / NCT04603300

OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut

NCT04603300 ↗

Phase 1 Completed 32 enrolled Intrommune Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2021-05-15
Primary completion
2023-06-30
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator INT301 Protein / enzyme biologic — Oral

Indications