NCT07228325

Comparative PK/PD of FMXIN002 and EpiPen, in Healthy Adults With Allergic Rhinitis

A Comparison of PK and PD Responses Following Single and Repeat Administration of Epinephrine Nasal FMXIN002 4.0 mg and EpiPen 0.3 mg, in Healthy Adults With Allergic Rhinitis

• Status: Enrolling By Invitation
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Nasus Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) responses of FMXIN002, an intranasal epinephrine powder, compared with the EpiPen® intramuscular autoinjector, after single and double doses, in healthy adults with a history of allergic rhinitis.

Detailed description

Fifty participants will receive single and repeat doses of both treatments under normal and nasal congestion conditions induced by nasal allergen challenge. The study will also assess the effect of repeat nasal dosing in the same versus opposite nostrils. PK parameters and hemodynamic responses will be measured, and safety and tolerability will be evaluated.

Conditions

• Anaphylaxis
• Allergy

Interventions

Type	Name	Description
DRUG	FMXIN002 single dose	Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions.
DRUG	Epinephrine autoinjector single dose	Epinephrine IM autoinjector 0.3mg
DRUG	FMXIN002 single dose + NAC	Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC)
DRUG	Epinephrine autoinjector double dose	Repeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart
DRUG	FMXIN002 double dose	Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart.
DRUG	FMXIN002 double dose + NAC	Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge, 10 minutes apart.

Timeline

• Start date: 2025-11-03
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2025-11-14
• Last updated: 2025-11-14

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study