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

NCT ID: NCT07228325

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-03
• Study Completion Date: 2026-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FMXIN002 Repeated doses in the same nostril

Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart.

Group Type: EXPERIMENTAL

FMXIN002 single dose

Intervention Type: DRUG

Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions.

Epinephrine autoinjector single dose

Intervention Type: DRUG

Epinephrine IM autoinjector 0.3mg

FMXIN002 single dose + NAC

Intervention Type: DRUG

Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC)

Epinephrine autoinjector double dose

Intervention Type: DRUG

Repeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart

FMXIN002 double dose

Intervention Type: DRUG

Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart.

FMXIN002 double dose + NAC

Intervention Type: DRUG

Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge, 10 minutes apart.

FMXIN002 Repeated doses in the opposite nostril

Repeated doses of epinephrine nasal powder spray, in both nostrils, 10 minutes apart.

Group Type: EXPERIMENTAL

FMXIN002 single dose

Intervention Type: DRUG

Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions.

Epinephrine autoinjector single dose

Intervention Type: DRUG

Epinephrine IM autoinjector 0.3mg

FMXIN002 single dose + NAC

Intervention Type: DRUG

Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC)

Epinephrine autoinjector double dose

Intervention Type: DRUG

Repeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart

FMXIN002 double dose

Intervention Type: DRUG

Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart.

FMXIN002 double dose + NAC

Intervention Type: DRUG

Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge, 10 minutes apart.

Interventions

FMXIN002 single dose

Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions.

Intervention Type: DRUG

Epinephrine autoinjector single dose

Epinephrine IM autoinjector 0.3mg

Intervention Type: DRUG

FMXIN002 single dose + NAC

Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC)

Intervention Type: DRUG

Epinephrine autoinjector double dose

Repeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart

Intervention Type: DRUG

FMXIN002 double dose

Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

NS002; EpiPen; NS002; EpiPen; NS002; NS002

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nasus Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark L Freedman, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Pharma Medica Research, Inc.

Locations

Pharma Medica Research Inc

Mississauga, , Canada

Countries

Canada

Other Identifiers

NP-007-Epinephrine

Identifier Type: -

Identifier Source: org_study_id