Study of the Safety and Local Tolerability of Intranasal Gel Formulations of XF-73

Exclusion Criteria

• •1. Female subjects who are pregnant or who are lactating.
• •2. Heterosexually active females of child-bearing potential, defined as being physiologically capable of becoming pregnant, unless they agree to use two of the following acceptable methods of contraception throughout their participation in the study and for at least 12 weeks after the final dose: (a) established use of oral, injected or implanted hormonal contraception, (b) intrauterine Device (IUD or Coil), (c) a female barrier method (diaphragm or cervical/vault cap) and/or (d) condom plus spermicidal cream/gel. Women who are not sexually active (abstinent) but become active must use two of the listed contraceptive methods.
• •3. Heterosexually active males unless they agree to use two concomitant acceptable methods of contraception throughout their participation in the study and for at least 12 weeks after receiving their final dose of study medication (examples include: vasectomy combined with latex condom with spermicide, latex condom with spermicide combined with a female partner who practices an acceptable method of contraception as indicated above); Men who are not sexually active (abstinent) but become active must use two of the listed contraceptive methods. Subjects who currently have or have had any acute illness within the past two weeks.
• •4. Subjects who currently have or have had within the past two weeks a poorly controlled chronic illness(anemia, thrombocytopenia, or coagulation disorders), cancer, infection, or any other clinically significant disorder.
• •5. Subjects who currently have or have had an autoimmune disease.
• •6. Subjects who have had within the past two weeks a symptomatic upper respiratory tract infection, nasopharyngitis, influenza or condition involving increase in nasal secretion such as seasonal or chronic, allergic rhinitis. Additionally, any subject with history of atopy/allergies within the past 30 days will be excluded.
• •7. Subjects who have had been diagnosed with a concussion within the past two years.
• •8. Subjects with a history of serious psychiatric condition (depression, bipolar disorder, schizophrenia, suicidal ideation, or suicide attempts) or receiving two concomitant medications for the treatment of a psychiatric disorder or hospitalized for the treatment of a serious psychiatric disorder within six months of participation in the study.
• •9. Subjects with known skin photosensitivity.
• •10. Subjects with a personal or family history of porphyria.
• •11. Subjects with any open wound, lesion, inflammation, erythema, or infection affecting the nostrils, nose, upper lip, and area of skin close to the nose, including herpes simplex lesions and discoid lupus.
• •12. Subjects with a history of abnormal bleeding, bruising, frequent nosebleeds, or the diagnosis of von Willebrand disease.
• •13. Subjects with nasal polyps or significant anatomical nasal abnormality. Patients with deviated septa will be allowed in the study, provided the principal investigator does not deem a deviation to be of significant medical consequence. An ENT(Ear, Nose and Throat) specialist will be available for consult as needed.
• •14. Subjects with a history of nasal surgery, including cauterization, in the last 6 months.
• •15. Subjects with a history of multiple episodes \[\>3\] of epistaxis within the 12 months prior to screening.
• •16. Subjects with in situ nasal jewelry or open nasal piercings.
• •17. Subjects with a known clinically significant history of atopy or hypersensitivity to any drug or latex or to ingredients of the nasal gel (such as benzalkonium chloride or other quaternary ammonium disinfectants) or to drugs related to XF-73.
• •18. Subjects known to have dermal sensitivity to chlorhexidine gluconate (CHG).
• •19. Subjects who have smoked within the month prior to screening.
• •20. Subjects who have been treated with or have taken any prescribed or over-the-counter medication daily for the last 14 days, with the exception of hormonal contraceptives or hormone replacement therapy.
• •21. Subjects who have taken or used topical or systemic antibiotics within the month prior to screening.
• •22. Subjects who have received an immunization within 30 days prior to screening.
• •23. Subjects with a history of drug or alcohol abuse in the last 12 months or who have a positive urine drug test for substances of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates, phencyclidine \[PCP\]) or alcohol.
• •24. Subjects who are known to have serum hepatitis, or who are carriers of the hepatitis B surface antigen(HBsAg) or hepatitis C (HCV) antibody, or who have a positive result to the test for human immunodeficiency virus (HIV) antibodies.
• •25. Subjects who have participated in a drug or vaccine clinical trial within the last month.
• •26. Subjects who have been exposed to XF-73 as part of a previous clinical trial.
• •27. Presence of any other condition or laboratory result that, in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.