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

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. -