A Safety and Immunogenicity Phase I Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid

Exclusion Criteria

• •1. Previous Japanese red cedar allergen immunotherapy (SCIT, oral immunotherapy, SLIT, or recombinant peptide)
• •2. History of anaphylaxis requiring medical intervention.
• •3. Intolerance of or severe allergic reaction to previous immunotherapy (SCIT, oral immunotherapy, SLIT, or recombinant peptide
• •4. History of asthma requiring daily medication with the exception of exercise induced asthma. (history of intermittent and/or mild asthma permitted)
• •5. Subjects receiving anti-IgE monoclonal antibodies.
• •6. Congenital immune deficiency or acquired immune suppression. Causes of acquired immune suppression may include, but are not limited to, systemic illnesses such as malignancy and infection, the use of medications such as corticosteroids and chemotherapeutic agents, and radiation therapy.
• •7. History of organ transplant, hematologic malignancy, autoimmune disease, myocardial infarction, or congestive heart failure.
• •8. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic diseases, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• •9. Inability or unwillingness to stop using drugs that may inhibit the ability to treat a severe allergic adverse event. This includes, but is not limited to; beta blockers such as atenolol (Tenormin), metoprolol (Lopressor, Toprol-XL) and propranolol (Inderal, Inderal LA) for 48 hours prior to Visit 1 and for the duration of the study. All subjects must be off of antihistamine therapy 7 days before skin testing.
• •10. Female subjects who are trying to conceive, are pregnant, or are lactating.
• •11. Positive serum pregnancy test at screening or a positive human chorionic gonadotropin (HCG) urine test on Visit 1 for women of childbearing potential.
• •12. Positive blood screen for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbSAg), or Hepatitis C.
• •13. FEV1 of \<70% as measure by spirometry.
• •14. Chronic history of recurrent sinusitis, urticaria or angioedema within the last 12 months.
• •15. History of alcohol or drug abuse within the year prior to the Screening Visit 1, or current evidence of substance dependence or abuse.
• •16. Laboratory Values (hematology, biochemistry, urine tests, PFT) that are outside the normal ranges, unless the abnormality is not considered clinically significant by the investigator.
• •17. Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to the Screening Visit.
• •18. Subjects with anti-LAMP antibodies above the Cutpoint Assay baseline will be excluded.