Trials / Completed
CompletedNCT04603300
OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut
Oral Mucosal Escalation Goal Assessment (OMEGA) Study: A Randomized Placebo-Controlled Phase 1 Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Intrommune Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-05-15
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
- First posted
- 2020-10-26
- Last updated
- 2023-07-28
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04603300. Inclusion in this directory is not an endorsement.