NCT04696822

Bioavailability of Nasal Epinephrine

Bioavailability Comparison of Epinephrine Following a Single Nasal Dose of Microspheres Powder With Epinephrine Intramuscular Injection in Adults With Seasonal Allergic Rhinitis With and Without Nasal Allergen Challenge

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Nasus Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Study to Compare the Bioavailability of Epinephrine following a Single Nasal Dose of FMXIN002 Microspheres Powder with Epinephrine 0.3 mg Intramuscular Injection in Adult Subjects with Seasonal Allergic Rhinitis with and without Nasal Allergen Challenge

Detailed description

Study Design: Open-label, single-dose, two-period, three-treatment, fixed-sequence, comparative bioavailability study Study Population: Non-smoking, male and female subjects, from 18 to 55 years of age with known history of hay fever, seasonal allergies, or rhinitis during the last year.

Conditions

• Anaphylaxis

Interventions

Type	Name	Description
DRUG	Epinephrine Nasal Product, 1.6 mg	Single dose Nasal powder spray without allergen challenge
DRUG	Epinephrine nasal product, 1.6 mg + allergen	Single dose Nasal powder spray with allergen challenge
DRUG	Epinephrine Injection 0.3 mg	Intramuscular injection
DRUG	Epinephrine Nasal Product, 3.2 mg	Twice dose Nasal powder spray without allergen challenge
DRUG	Epinephrine Nasal Product, 3.2 mg + allergen	Twice dose Nasal powder spray with allergen challenge

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-09-28
• Completion: 2021-09-28
• First posted: 2021-01-06
• Last updated: 2024-01-05

Locations

1 site across 1 country: Israel