A Phase III Study of ARS-1 Administration in Patients with Food Allegy

Phase 3

• Conditions: Anaphylactic Symptoms Induced by An Oral Food Challenge Test

• Registration Number: JPRN-jRCT2031230143
• Lead Sponsor: Kenya Morita

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Between the ages of 4 and 55 years at IC
2. Has body weight 15 kg or higher before OFC test at Day1
3. Is scheduled for an inpatient oral food challenge test.
4. Must have an oral food allergy that elicited symptoms of grade 2 or higher gastrointestinal, respiratory, or circulatory symptoms according to the Severity Classification of Organ Symptoms Induced by Anaphylaxis in the Anaphylaxis Guidelines of the Japanese Society of Allergology.

Exclusion Criteria

1. Has prior nasal fractures, severe nasal injuries, history of nasal disorders, any nasal conditions that could interfere with nasal spray administration, abuse of nasal decongestants, or sleep apnea.
2. Has used nasal drugs within 14 days from Day1.
3. Has mucosal inflammatory disorders (e.g., pemphigus or Sjogren's syndrome or fungal sinusitis).
4. Known hypersensitivity to any compound in sympathomimetics or any compounds contained in investigational drugs (adrenaline, n-dodecyl-beta-D-maltoside, sodium edetate hydrate, benzalkonium chloride, sodium pyrosulfite) or other closely related compound.

Study & Design

• Study Type: Interventional
• Study Design: Not specified