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NCT04856865 · ClinicalTrials.gov registry record · Phase 1
ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
A Phase 1 study of Food Allergy, sponsored by Alladapt Immunotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
- 15
- Study locations
NCT04856865: Completed Phase 1 study of Food Allergy, sponsored by Alladapt Immunotherapeutics.
NCT04856865 is a Phase 1 study of Food Allergy that has completed, run by Alladapt Immunotherapeutics. The registered enrollment target is 73 participants, below the 960-participant average among 17 other Food Allergy trials with a reported enrollment target (92% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04856865, a Phase 1 study of Food Allergy, has completed, sponsored by Alladapt Immunotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
Primary Outcome
The proportion of participants in the pediatric ITT population who tolerated the 600mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC.
Conditions Studied
Interventions
- BIOLOGICAL Low dose ADP101
- BIOLOGICAL High dose ADP101
- BIOLOGICAL Pooled Placebo
Study Locations (15)
California
- Study Site - Mission Viejo
- Study Site - Rolling Hills Estates
- Study Site - San Diego
Georgia
- Study Site - Atlanta
- Study Site - Marietta
Colorado
- Study Site - Denver
Florida
- Study Site - Tampa
Illinois
- Study Site - Normal
Michigan
- Study Site - Ann Arbor
North Carolina
- Study Site - Chapel Hill
Ohio
- Study Site - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2021-04-20 |
| Est. Completion | 2022-12-13 |
| Phase | Phase 1 |
What the finished NCT04856865 record still lists
NCT04856865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 960-participant average among 17 other Food Allergy trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Food Allergy appearing as the primary indexed condition, and to 3 interventions - of which Low dose ADP101 is the first listed.
NCT04856865 lists 15 locations in 12 states (California, Georgia, Colorado).
Frequently Asked Questions
What is clinical trial NCT04856865 about?
NCT04856865 is a clinical study titled "ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults". The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
What is the current status of trial NCT04856865?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2021-04-20. Estimated completion is 2022-12-13.
What conditions does trial NCT04856865 study?
This clinical trial studies the following conditions: Food Allergy.
What interventions are being tested in trial NCT04856865?
The interventions under investigation include: Low dose ADP101 (BIOLOGICAL), High dose ADP101 (BIOLOGICAL), Pooled Placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT04856865?
This trial is sponsored by Alladapt Immunotherapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04856865 being conducted?
This trial has 15 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Food Allergy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04856865's enrollment target sits among peer trials
73 8th of 17 higher than 9 of 17 other Food Allergy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Food Allergy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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