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Comparative PK/PD of FMXIN002 and EpiPen, in Healthy Adults With Allergic Rhinitis
Sponsor: Nasus Pharma
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.
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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-11-03
Completion Date
2026-04
Last Updated
2025-11-14
Healthy Volunteers
Yes
Conditions
Interventions
FMXIN002 single dose
Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions.
Epinephrine autoinjector single dose
Epinephrine IM autoinjector 0.3mg
FMXIN002 single dose + NAC
Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC)
Epinephrine autoinjector double dose
Repeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart
FMXIN002 double dose
Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart.
FMXIN002 double dose + NAC
Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge, 10 minutes apart.
Locations (1)
Pharma Medica Research Inc
Mississauga, Canada