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ENROLLING BY INVITATION
NCT07228325
PHASE1/PHASE2

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

Sponsor: Nasus Pharma

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-11-03

Completion Date

2026-04

Last Updated

2025-11-14

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Pharma Medica Research Inc

Mississauga, Canada