Comparative PK/PD of FMXIN002 and EpiPen, in Healthy Adults With Allergic Rhinitis
- Conditions
- AnaphylaxisAllergy
- Interventions
- Drug: FMXIN002 single doseDrug: Epinephrine autoinjector single doseDrug: FMXIN002 single dose + NACDrug: Epinephrine autoinjector double doseDrug: FMXIN002 double doseDrug: FMXIN002 double dose + NAC
- Registration Number
- NCT07228325
- Lead Sponsor
- Nasus Pharma
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 50
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Non-smoking, male and female participants, from 18 to 55 years of age.
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Documented positive skin allergy test at screening.
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History of hay fever, seasonal allergies, or allergic rhinitis during the last year.
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BMI ≥18 and < =30 kg/m2.
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Females may be of childbearing or non-childbearing potential:
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Childbearing potential:
o Physically capable of becoming pregnant, must be willing to use acceptable effective methods of contraception.
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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).
-
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Able to tolerate venipuncture.
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Be informed of the nature of the study and give written consent prior to any study procedure.
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Willing and able to remain in the clinic for the entire duration of the confinement period.
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Have good intravenous access on both arms and hands. -
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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.
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Have clinically significant findings at screening.
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description FMXIN002 Repeated doses in the same nostril FMXIN002 single dose Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart. FMXIN002 Repeated doses in the same nostril Epinephrine autoinjector single dose Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart. FMXIN002 Repeated doses in the same nostril FMXIN002 single dose + NAC Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart. FMXIN002 Repeated doses in the same nostril Epinephrine autoinjector double dose Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart. FMXIN002 Repeated doses in the same nostril FMXIN002 double dose Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart. FMXIN002 Repeated doses in the same nostril FMXIN002 double dose + NAC Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart. FMXIN002 Repeated doses in the opposite nostril FMXIN002 single dose Repeated doses of epinephrine nasal powder spray, in both nostrils, 10 minutes apart. FMXIN002 Repeated doses in the opposite nostril Epinephrine autoinjector single dose Repeated doses of epinephrine nasal powder spray, in both nostrils, 10 minutes apart. FMXIN002 Repeated doses in the opposite nostril FMXIN002 single dose + NAC Repeated doses of epinephrine nasal powder spray, in both nostrils, 10 minutes apart. FMXIN002 Repeated doses in the opposite nostril Epinephrine autoinjector double dose Repeated doses of epinephrine nasal powder spray, in both nostrils, 10 minutes apart. FMXIN002 Repeated doses in the opposite nostril FMXIN002 double dose Repeated doses of epinephrine nasal powder spray, in both nostrils, 10 minutes apart. FMXIN002 Repeated doses in the opposite nostril FMXIN002 double dose + NAC Repeated doses of epinephrine nasal powder spray, in both nostrils, 10 minutes apart.
- Primary Outcome Measures
Name Time Method Epinephrine level in plasma over time -60 to 240 minutes post administration Measurements in 14 timepoints
Tmax -60 to 240 minutes post administration Time to maximum epinephrine level in plasma
T100pg/ml -60 to 240 minutes post administration Time to reach epinephrine level of 100pg/ml in plasma
Cmax -60 to 240 minutes post administration Maximum epinephrine level in plasma
AUC 0 to 240 minutes post administration Total exposure to epinephrine
Blood pressure -60 to 120 minutes post administration Pharmacodynamic response to epinephrine
Heart rate -60 to 120 minutes post administration Pharmacodynamic response to epinephrine
Respiratory rate -60 to 120 minutes post administration Pharmacodynamic response to epinephrine
- Secondary Outcome Measures
Name Time Method Safety and tolerability Day -29 to day 50 Adverse events rate at each treatment, and severity.
Trial Locations
- Locations (1)
Pharma Medica Research Inc
🇨🇦Mississauga, Canada
Pharma Medica Research Inc🇨🇦Mississauga, Canada