A Phase 1/2 interventional study of FMXIN002 single dose and Epinephrine autoinjector single dose in Anaphylaxis and Allergy, sponsored by Nasus Pharma. Enrolling by invitation at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-14.
Sponsored by Nasus Pharma · Phase 1/2, Interventional, and Treatment
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.
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.
100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 50 interventional studies indexed under Anaphylaxis.
Browse Anaphylaxis studies →Nasus Pharma is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Females may be of childbearing or non-:
Childbearing potential:
o Physically capable of becoming pregnant, must be willing to use acceptable effective methods of .
Non-childbearing potential:
Exclusion Criteria:
Females who:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions.
Also known as: NS002
Epinephrine IM autoinjector 0.3mg
Also known as: EpiPen
Drug page: Acetylcysteine
Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC)
Also known as: NS002
Repeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart
Also known as: EpiPen
Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart.
Also known as: NS002
Drug page: Acetylcysteine
Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge, 10 minutes apart.
Also known as: NS002
Epinephrine level in plasma over time
Measurements in 14 timepoints
Time frame: -60 to 240 minutes post administration
Tmax
Time to maximum epinephrine level in plasma
Time frame: -60 to 240 minutes post administration
T100pg/ml
Time to reach epinephrine level of 100pg/ml in plasma
Time frame: -60 to 240 minutes post administration
Cmax
Maximum epinephrine level in plasma
Time frame: -60 to 240 minutes post administration
AUC
Total exposure to epinephrine
Time frame: 0 to 240 minutes post administration
Blood pressure
Pharmacodynamic response to epinephrine
Time frame: -60 to 120 minutes post administration
Heart rate
Pharmacodynamic response to epinephrine
Time frame: -60 to 120 minutes post administration
Respiratory rate
Pharmacodynamic response to epinephrine
Time frame: -60 to 120 minutes post administration
Safety and tolerability
Adverse events rate at each treatment, and severity.
Time frame: Day -29 to day 50
Plan to share: Undecided — We will share documents as required by the future scientific journal of choice.
No publications or documents are linked to this record.
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Studies of the drugs tested here: Epinephrine · Acetylcysteine
Nasus Pharma