A Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine
NCT03755713 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-10-23
Summary
The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal (ID) injection in adolescent participants with peanut allergy.
Conditions
Interventions
- DRUG
-
ASP0892
Intradermal
- DRUG
-
Intradermal; normal saline solution
Sponsors & Collaborators
-
Astellas Pharma Global Development, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Monitor, Senior Medical Director · Astellas Pharma Global Development, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-12
- Primary Completion
- 2021-10-11
- Completion
- 2021-10-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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