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

NCT07228325 | Enrolling By Invitation Phase 1 FDA Drug

• 1 other identifier: NP-007-Epinephrine
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaphylaxis; Allergy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Safety and tolerability

  Day -29 to day 50

Study Arms (2)

FMXIN002 Repeated doses in the same nostril

EXPERIMENTAL

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

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

FMXIN002 Repeated doses in the opposite nostril

EXPERIMENTAL

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

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

Interventions

FMXIN002 single dose DRUG

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

Also known as: NS002

FMXIN002 Repeated doses in the opposite nostril; FMXIN002 Repeated doses in the same nostril

Epinephrine autoinjector single dose DRUG

Epinephrine IM autoinjector 0.3mg

Also known as: EpiPen

FMXIN002 Repeated doses in the opposite nostril; FMXIN002 Repeated doses in the same nostril

FMXIN002 single dose + NAC DRUG

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

Also known as: NS002

FMXIN002 Repeated doses in the opposite nostril; FMXIN002 Repeated doses in the same nostril

Epinephrine autoinjector double dose DRUG

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

Also known as: EpiPen

FMXIN002 Repeated doses in the opposite nostril; FMXIN002 Repeated doses in the same nostril

FMXIN002 double dose DRUG

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

Also known as: NS002

FMXIN002 Repeated doses in the opposite nostril; FMXIN002 Repeated doses in the same nostril

FMXIN002 double dose + NAC DRUG

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

Also known as: NS002

FMXIN002 Repeated doses in the opposite nostril; FMXIN002 Repeated doses in the same nostril

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoking, male and female participants, from 18 to 55 years of age.
• Documented positive skin allergy test at screening.
• History of hay fever, seasonal allergies, or allergic rhinitis during the last year.
• BMI ≥18 and \< =30 kg/m2.
• 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).
• Able to tolerate venipuncture.
• Be informed of the nature of the study and give written consent prior to any study procedure.
• Willing and able to remain in the clinic for the entire duration of the confinement period.
• Have good intravenous access on both arms and hands. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nasus Pharma: lead

Study Sites (1)

Pharma Medica Research Inc

Mississauga, Canada

Location

MeSH Terms

Conditions

Anaphylaxis; Hypersensitivity

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Mark L Freedman, MD, FRCPC

  Pharma Medica Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 14, 2025
• Study Start: November 3, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

CA (1)