AnaphylaxisPhase 1/2NCT07228325
Comparative PK/PD of FMXIN002 and EpiPen, in Healthy Adults With Allergic Rhinitis
A Phase 1/2 study testing FMXIN002 single dose, Epinephrine autoinjector single dose and FMXIN002 single dose + NAC in people with Anaphylaxis and Allergy, run by Nasus Pharma at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaphylaxis, Allergy
- What is being tested?
- FMXIN002 single dose, Epinephrine autoinjector single dose and FMXIN002 single dose + NAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 3 Nov 2025to Apr 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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. -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- FMXIN002 single dose, Epinephrine autoinjector single dose, FMXIN002 single dose + NAC, Epinephrine autoinjector double dose, FMXIN002 double dose
- Medical subject headings
- Anaphylaxis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMXIN002 single doseDrug
Also called NS002
Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions.
Epinephrine autoinjector single doseDrug
Also called EpiPen
Epinephrine IM autoinjector 0.3mg
FMXIN002 single dose + NACDrug
Also called NS002
Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC)
Epinephrine autoinjector double doseDrug
Also called EpiPen
Repeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart
FMXIN002 double doseDrug
Also called NS002
Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart.
FMXIN002 double dose + NACDrug
Also called NS002
Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge, 10 minutes apart.
| Study group | Role | What they receive |
|---|---|---|
| FMXIN002 Repeated doses in the same nostril | Experimental | Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epinephrine level in plasma over time
Measurements in 14 timepoints
Measured: -60 to 240 minutes post administration
Tmax
Time to maximum epinephrine level in plasma
Measured: -60 to 240 minutes post administration
T100pg/ml
Time to reach epinephrine level of 100pg/ml in plasma
Measured: -60 to 240 minutes post administration
Cmax
Maximum epinephrine level in plasma
Measured: -60 to 240 minutes post administration
AUC
Total exposure to epinephrine
Measured: 0 to 240 minutes post administration
Blood pressure
Pharmacodynamic response to epinephrine
Measured: -60 to 120 minutes post administration
Heart rate
Pharmacodynamic response to epinephrine
Measured: -60 to 120 minutes post administration
Respiratory rate
Pharmacodynamic response to epinephrine
Measured: -60 to 120 minutes post administration
Secondary outcomes (1)
Safety and tolerability
Adverse events rate at each treatment, and severity.
Measured: Day -29 to day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start3 Nov 2025
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nasus Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark L Freedman, MD, FRCPC, Principal investigator, Pharma Medica Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228325
- Sponsor's protocol ID
- NP-007-Epinephrine
- Status last verified
- Nov 2025
- First submitted
- 6 Nov 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share documents as required by the future scientific journal of choice.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07228325
- Acronym / sponsor ID
- NP-007-Epinephrine
- Conditions
- Anaphylaxis, Allergy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nasus PharmaIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMXIN002 Repeated doses in the same nostril | Experimental | 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 + NACRepeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart. |
| FMXIN002 Repeated doses in the opposite nostril | Experimental | 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 + NACRepeated doses of epinephrine nasal powder spray, in both nostrils, 10 minutes apart. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMXIN002 single doseAlso: NS002Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions. | Drug | FMXIN002 Repeated doses in the opposite nostril, FMXIN002 Repeated doses in the same nostril |
| Epinephrine autoinjector single doseAlso: EpiPenEpinephrine IM autoinjector 0.3mg | Drug | FMXIN002 Repeated doses in the opposite nostril, FMXIN002 Repeated doses in the same nostril |
| FMXIN002 single dose + NACAlso: NS002Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC) | Drug | FMXIN002 Repeated doses in the opposite nostril, FMXIN002 Repeated doses in the same nostril |
| Epinephrine autoinjector double doseAlso: EpiPenRepeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart | Drug | FMXIN002 Repeated doses in the opposite nostril, FMXIN002 Repeated doses in the same nostril |
| FMXIN002 double doseAlso: NS002Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart. | Drug | FMXIN002 Repeated doses in the opposite nostril, FMXIN002 Repeated doses in the same nostril |
| FMXIN002 double dose + NACAlso: NS002Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge, 10 minutes apart. | Drug | FMXIN002 Repeated doses in the opposite nostril, FMXIN002 Repeated doses in the same nostril |
Primary outcome
Epinephrine level in plasma over time
Time frame: -60 to 240 minutes post administration
Measurements in 14 timepoints
Tmax
Time frame: -60 to 240 minutes post administration
Time to maximum epinephrine level in plasma
T100pg/ml
Time frame: -60 to 240 minutes post administration
Time to reach epinephrine level of 100pg/ml in plasma
Cmax
Time frame: -60 to 240 minutes post administration
Maximum epinephrine level in plasma
AUC
Time frame: 0 to 240 minutes post administration
Total exposure to epinephrine
Blood pressure
Time frame: -60 to 120 minutes post administration
Pharmacodynamic response to epinephrine
Heart rate
Time frame: -60 to 120 minutes post administration
Pharmacodynamic response to epinephrine
Respiratory rate
Time frame: -60 to 120 minutes post administration
Pharmacodynamic response to epinephrine
1 secondary outcome
Safety and tolerability
Time frame: Day -29 to day 50
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: Undecided. We will share documents as required by the future scientific journal of choice.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark L Freedman, MD, FRCPC principal investigator
Pharma Medica Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FMXIN002 single dose, Epinephrine autoinjector single dose and FMXIN002 single dose + NAC in people with Anaphylaxis and Allergy, run by Nasus Pharma at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epinephrine level in plasma over time (time frame: -60 to 240 minutes post administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.