Comparative PK/PD of FMXIN002 and EpiPen, in Healthy Adults With Allergic Rhinitis

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.

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.

Inclusion Criteria:

1. Non-smoking, male and female participants, from 18 to 55 years of age.

2. Documented positive skin allergy test at screening.

3. History of hay fever, seasonal allergies, or allergic rhinitis during the last year.

4. BMI ≥18 and < =30 kg/m2.

5. Females may be of childbearing or non-childbearing potential:

   • Childbearing potential:

     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).

6. Able to tolerate venipuncture.

7. Be informed of the nature of the study and give written consent prior to any study procedure.

8. Willing and able to remain in the clinic for the entire duration of the confinement period.

9. Have good intravenous access on both arms and hands. -

Exclusion Criteria:

• 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.