ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
Brief 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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: April 20, 2021
Estimated Primary Completion Date: November 2022
Estimated Study Completion Date: December 2022
Arm:
- Experimental: Arm 1
- Experimental: Arm 2
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 72 |
| Actual Study start date | 20 April 2021 |
| Estimated Study Completion Date | 01 December 2022 |