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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions.
Epinephrine IM autoinjector 0.3mg
Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC)
Pharma Medica Research Inc
Mississauga, Canada
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.
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Repeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart
Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart.
Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge, 10 minutes apart.
Time frame: Day -29 to day 50