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

JRCT ID: jRCT2031230143

Registered date:16/06/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Anaphylactic Symptoms Induced by An Oral Food Challenge Test
• Date of first enrollment: 18/07/2023
• Target sample size: 15
• Study type: Interventional

Intervention(s)

Subjects 15 to <30kg body weight will receive a single 1.0mg/100microL Intranasal dose of ARS-1 in a nare.
Subjects 30 kg or greater body weight will receive a single 2.0mg/100microL Intranasal dose of ARS-1 in a nare.

Outcome(s)

• Primary Outcome: Change from baseline in main symptoms at 15 minutes after an administration of ARS-1 or at the final evaluation before alternative treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 4age old
• Age maximum: <= 55age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kenya Morita