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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Allergy; Anaphylaxis
• Intervention / Treatment: Drug: FMXIN002 single dose; Drug: Epinephrine autoinjector single dose; Drug: FMXIN002 single dose + NAC; Drug: Epinephrine autoinjector double dose; Drug: FMXIN002 double dose; Drug: FMXIN002 double dose + NAC

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Mississauga, Canada
    • Pharma Medica Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Non-smoking, male and female participants, from 18 to 55 years of age.
2. Documented positive skin allergy test at screening.
3. History of hay fever, seasonal allergies, or allergic rhinitis during the last year.
4. BMI ≥18 and < =30 kg/m2.

5. Females may be of childbearing or non-childbearing potential:

   • Childbearing potential:

     o Physically capable of becoming pregnant, must be willing to use acceptable effective methods of contraception.

   • Non-childbearing potential:

     • Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or
     • Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause and a FSH value consistent with being postmenopausal).
6. Able to tolerate venipuncture.
7. Be informed of the nature of the study and give written consent prior to any study procedure.
8. Willing and able to remain in the clinic for the entire duration of the confinement period.
9. Have good intravenous access on both arms and hands. -

Exclusion Criteria:

• History of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results.
• Have clinically significant findings at screening.

• Females who:

  • Have discontinued or changed the use of implanted, intrauterine, intravaginal, or injected hormonal contraceptives within 6 months prior to the first drug administration;
  • Have discontinued or changed the use of oral or patch hormonal contraceptives within one (1) month prior to the first drug administration;
  • Are pregnant (serum β-hCG consistent with pregnancy); or
  • Are breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMXIN002 Repeated doses in the same nostril; Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart.	Drug: FMXIN002 single dose; Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions.; Other Names: NS002; Drug: Epinephrine autoinjector single dose; Epinephrine IM autoinjector 0.3mg; Other Names: EpiPen; Drug: FMXIN002 single dose + NAC; Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC); Other Names: NS002; Drug: Epinephrine autoinjector double dose; Repeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart; Other Names: EpiPen; Drug: FMXIN002 double dose; Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart.; Other Names: NS002; 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.; Other Names: NS002
Experimental: FMXIN002 Repeated doses in the opposite nostril; Repeated doses of epinephrine nasal powder spray, in both nostrils, 10 minutes apart.	Drug: FMXIN002 single dose; Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions.; Other Names: NS002; Drug: Epinephrine autoinjector single dose; Epinephrine IM autoinjector 0.3mg; Other Names: EpiPen; Drug: FMXIN002 single dose + NAC; Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC); Other Names: NS002; Drug: Epinephrine autoinjector double dose; Repeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart; Other Names: EpiPen; Drug: FMXIN002 double dose; Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart.; Other Names: NS002; 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.; Other Names: NS002

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epinephrine level in plasma over time	Measurements in 14 timepoints	-60 to 240 minutes post administration
Tmax	Time to maximum epinephrine level in plasma	-60 to 240 minutes post administration
T100pg/ml	Time to reach epinephrine level of 100pg/ml in plasma	-60 to 240 minutes post administration
Cmax	Maximum epinephrine level in plasma	-60 to 240 minutes post administration
AUC	Total exposure to epinephrine	0 to 240 minutes post administration
Blood pressure	Pharmacodynamic response to epinephrine	-60 to 120 minutes post administration
Heart rate	Pharmacodynamic response to epinephrine	-60 to 120 minutes post administration
Respiratory rate	Pharmacodynamic response to epinephrine	-60 to 120 minutes post administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	Adverse events rate at each treatment, and severity.	Day -29 to day 50

Collaborators and Investigators

• Sponsor: Nasus Pharma
• Investigators: Principal Investigator: Mark L Freedman, MD, FRCPC, Pharma Medica Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 6, 2025
• First Submitted That Met QC Criteria: November 11, 2025
• First Posted (Estimated): November 14, 2025

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Anaphylaxis; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Catechols; Phenols; Benzene Derivatives; Alcohols; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Epinephrine
• Other Study ID Numbers: NP-007-Epinephrine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will share documents as required by the future scientific journal of choice.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes