NCT06205134

Comparative Bioavailability of Intranasal Epinephrine

A Study to Compare the Bioavailability of Epinephrine Following a Single Nasal Dose of FMXIN002 Microspheres Powder 3.6mg, and 4mg With EpiPen 0.3mg Intramuscular Injection in Healthy Adults

• Status: Completed
• Phase: Phase 1 / Phase 2
• 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 3.6 mg, and 4mg with EpiPen 0.3mg Intramuscular Injection in Healthy Adults

Detailed description

An open-label trial in 12 healthy adults. FMXIN002 (3.6 mg and 4.0 mg) will be administered intranasally to healthy adults and compared to IM (0.3mg, EpiPen) by Epinephrine pharmacokinetics, pharmacodynamic response and clinical safety. (https://my.health.gov.il/CliniTrials/Pages/MOH\_2023-07-01\_012776.aspx.)

Conditions

• Anaphylaxis
• Anaphylactic Reaction

Interventions

Type	Name	Description
DRUG	A: Epinephrine injection	Autoinjector for intramuscular, single-use, 0.3mg
DRUG	B: FMXIN002 3.6mg	Nasus Pharma nasal powder spray 3.6 mg, single use in one nostril
DRUG	C: FMXIN002 4.0mg	Nasus Pharma nasal powder spray 4.0 mg, single use in one nostril

Timeline

• Start date: 2023-08-22
• Primary completion: 2024-02-02
• Completion: 2024-02-05
• First posted: 2024-01-12
• Last updated: 2025-06-18

Locations

1 site across 1 country: Israel