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

NCT07228325 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-14

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Nasus Pharma

    lead INDUSTRY

Principal Investigators

  • Mark L Freedman, MD, FRCPC · Pharma Medica Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2026-03-31
Completion
2026-04-30
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07228325 on ClinicalTrials.gov