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ASP0892Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D021183 Peanut Hypersensitivity NIH 0.71

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 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

The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal (ID) injection in adolescent participants with peanut allergy.

NCT03755713 Peanut Allergy Drug: ASP0892 Drug: Placebo
MeSH:Peanut Hypersensitivity

Primary Outcomes

Description: 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.

Measure: Safety as assessed by Treatment Emergent Adverse Events (TEAEs)

Time: Up to Day 576

Description: 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).

Measure: Safety as assessed by local reactogenicity reactions

Time: Up to Day 50

Description: 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).

Measure: Safety as assessed by systemic reactogenicity reactions

Time: Up to Day 50

Description: Number of participants with potentially clinically significant vital sign values.

Measure: Number of participants with vital signs abnormalities and/or adverse events

Time: Up to Day 576

Description: Number of participants with potentially clinically significant laboratory values.

Measure: Number of participants with laboratory value abnormalities and/or adverse events

Time: Up to Day 576

Description: Anti-LAMP-1 antibody formation for all participants will be summarized for each treatment by visit using descriptive statistics.

Measure: Safety assessed by Anti-LAMP-1 antibody

Time: Up to Day 576

No related HPO nodes (Using clinical trials)