Clinical Trial Finder

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

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.

Arms

Experimental: Arm 1

Experimental: Arm 2

Interventions

Biological: - ADP101 vs Placebo Dose Regimen A

Active powder formulation at various volumes. Placebo powder formulation at various volumes.

Biological: - ADP101 vs Placebo Dose Regimen B

Active powder formulation at various volumes. Placebo powder formulation at various volumes.