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

November 11, 2025 updated by: Nasus Pharma

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Mississauga, Canada
        • Pharma Medica Research Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Epinephrine level in plasma over time
Time Frame: -60 to 240 minutes post administration
Measurements in 14 timepoints
-60 to 240 minutes post administration
Tmax
Time Frame: -60 to 240 minutes post administration
Time to maximum epinephrine level in plasma
-60 to 240 minutes post administration
T100pg/ml
Time Frame: -60 to 240 minutes post administration
Time to reach epinephrine level of 100pg/ml in plasma
-60 to 240 minutes post administration
Cmax
Time Frame: -60 to 240 minutes post administration
Maximum epinephrine level in plasma
-60 to 240 minutes post administration
AUC
Time Frame: 0 to 240 minutes post administration
Total exposure to epinephrine
0 to 240 minutes post administration
Blood pressure
Time Frame: -60 to 120 minutes post administration
Pharmacodynamic response to epinephrine
-60 to 120 minutes post administration
Heart rate
Time Frame: -60 to 120 minutes post administration
Pharmacodynamic response to epinephrine
-60 to 120 minutes post administration
Respiratory rate
Time Frame: -60 to 120 minutes post administration
Pharmacodynamic response to epinephrine
-60 to 120 minutes post administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: Day -29 to day 50
Adverse events rate at each treatment, and severity.
Day -29 to day 50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nasus Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark L Freedman, MD, FRCPC, Pharma Medica Research, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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