ASP0892
DrugIntradermal
NCT Number: NCT03755713
The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal (ID) injection in adolescent participants with peanut allergy.
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Notify Me12 year–17 year
All sexes
Interventional
Phase 1
Arkansas Children's Hospital Research Institute, Little Rock, Arkansas, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intradermal
Intradermal; normal saline solution
Time frame: Up to Day 576
Adverse Events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). AEs starting or worsening after the first dose of study drug up through study completion will be considered treatment-emergent.
Time frame: Up to Day 50
Participants will be asked to record local reactogenicity (pain, tenderness; erythema/redness, Induration/Swelling) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (Potentially Life Threatening).
Time frame: Up to Day 50
Participants will be asked to record systemic reactogenicity (nausea/vomiting, diarrhea, headache, fatigue, myalgia) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (Potentially Life Threatening).
Time frame: Up to Day 576
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to Day 576
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to Day 576
Anti-LAMP-1 antibody formation for all participants will be summarized for each treatment by visit using descriptive statistics.
Astellas Pharma Global Development, Inc.
Industry
A Phase 1, Randomized, Placebo-Controlled 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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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