ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

Alladapt Immunotherapeutics, Inc. (Industry)
Overall Status
Active, not recruiting ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: ADP101 vs Placebo Dose Regimen A
  • Biological: ADP101 vs Placebo Dose Regimen B
Phase 1/Phase 2

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.

Study Design

Study Type:
Actual Enrollment :
73 participants
Intervention Model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Official Title:
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)
Actual Study Start Date :
Apr 20, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Biological: ADP101 vs Placebo Dose Regimen A
Active powder formulation at various volumes. Placebo powder formulation at various volumes.

Experimental: Arm 2

Biological: ADP101 vs Placebo Dose Regimen B
Active powder formulation at various volumes. Placebo powder formulation at various volumes.

Outcome Measures

Primary Outcome Measures

  1. Food Allergy Desensitization [Week 40]

    The proportion of subjects who tolerate a highest dose of at least 600-mg of protein from a relevant allergen or allergens with no more than mild symptoms at the final/exit double-blind placebo-controlled food challenge.

Eligibility Criteria


Ages Eligible for Study:
4 Years to 55 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Age 4 to 55 (inclusive)

  • Clinical history of allergy to at least 1 of the foods contained in ADP101

  • Experience dose-limiting symptoms at or below the 100-mg dose level to 1 or multiple food sources in ADP101

Exclusion Criteria:
  • Experience dose limiting symptoms at or below the 100 mg challenge dose level to more than 5 food sources contained in ADP101

  • History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock within 60 days of screening

  • History of EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia

  • Severe asthma

  • Mild or moderate asthma, if uncontrolled or difficult to control

  • History of mast cell disorder, including mastocytosis, urticaria pigmentosa or angioedema

  • History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) at risk of becoming unstable or requiring a change in chronic therapeutic regimen e.g. uncontrolled diabetes

  • History of cardiovascular disease, including hypertension requiring > 2 antihypertensive medications

  • History of interstitial lung disease

  • History of celiac disease

  • Active autoimmune disease that has required systemic treatment within 3 months

  • Known malignancy that is progressing or has required active treatment within the past 3 years

  • Known history of HIV, known active hepatitis B infection or known active hepatitis C virus infection

  • Prior/concurrent therapies as follows:

  • beta-blockers, ACE inhibitors, ARBs or calcium channel blockers

  • regular steroid medication use

  • therapeutic antibody treatment currently or within the previous 6 months

  • any food immunotherapy currently or within the previous 12 weeks

  • In the build up phase of non-food immunotherapy

  • Residing at the same address as another subject (e.g. siblings) participating in this or any other OIT study

  • Develops dose-limiting symptoms to placebo during the Screening DBPCFC

  • Any other condition that might preclude safe participation in the study

Contacts and Locations


Site City State Country Postal Code
1 Study Site Mission Viejo California United States 92691
2 Study Site Rolling Hills Estates California United States 90274
3 Study Site San Diego California United States 92123
4 Study Site Denver Colorado United States 80230
5 Study Site Tampa Florida United States 33620
6 Study Site Atlanta Georgia United States 30329
7 Study Site Marietta Georgia United States 30060
8 Study Site Normal Illinois United States 61761
9 Study Site Ann Arbor Michigan United States 48108
10 Study Site Chapel Hill North Carolina United States 27599
11 Study Site Cincinnati Ohio United States 45229
12 Study Site Happy Valley Oregon United States 97086
13 Study Site Philadelphia Pennsylvania United States 19104
14 Study Site Charleston South Carolina United States 29420
15 Study Site Seattle Washington United States 98115

Sponsors and Collaborators

  • Alladapt Immunotherapeutics, Inc.


  • Study Director: Mei-Lun Wang, MD, VP of Clinical Development, Alladapt Immunotherapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Alladapt Immunotherapeutics, Inc. Identifier:
Other Study ID Numbers:
  • ADP101-MA-01
First Posted:
Apr 23, 2021
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Alladapt Immunotherapeutics, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2022