NCT02851277

A Study to Evaluate Safety, Tolerability and Immune Response in Adults Allergic to Peanut After Receiving Intradermal or Intramuscular Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine

A Phase 1, Randomized, Placebo Controlled Study to Evaluate Safety, Tolerability and Immune Response in Adults Allergic to Peanut After Receiving Intradermal or Intramuscular Administration of ASP0892 (ARA LAMP Vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal or intramuscular injection in adults with peanut allergy.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
DRUG	ASP0892 Intradermal	Intradermal injection
DRUG	ASP0892 Intramuscular	Intramuscular injection
DRUG	Placebo Intradermal	Intradermal injection
DRUG	Placebo Intramuscular	Intramuscular injection

Timeline

• Start date: 2016-12-13
• Primary completion: 2018-12-06
• Completion: 2018-12-06
• First posted: 2016-08-01
• Last updated: 2024-10-23

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study