NCT04856865

ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Harmony Study)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Alladapt Immunotherapeutics, Inc. · Industry
• Sex: All
• Age: 4 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of ADP101 for oral immunotherapy in food allergic children and adults.

Conditions

• Food Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Low dose ADP101	Active powder formulation
BIOLOGICAL	High dose ADP101	Active powder formulation.
BIOLOGICAL	Pooled Placebo	Placebo powder

Timeline

• Start date: 2021-04-20
• Primary completion: 2022-11-22
• Completion: 2022-12-13
• First posted: 2021-04-23
• Last updated: 2024-05-16
• Results posted: 2024-05-16

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study