A Study of ATI-502 Topical Solution for the Treatment of Atopic Dermatitis

Exclusion Criteria

• •1. Subject has any signs or symptoms associated with AD therapy which, in the investigator's opinion, might impair evaluation of the AD or which exposes the subject to unacceptable risk by study participation.
• •2. Subjects unable to complete the required washout periods. Use of prescription moisturizers within 7 days of Visit 1.
• •3. Subject has used any emollients/moisturizers on the planned treatment area (s) within 4 hours of Visit 1.
• •4. Subject has clinically infected AD.
• •5. Subject is currently using an oral H1 antihistamines (e.g. diphenhydramine, terfenadine) UNLESS the subject is on a stable dose for at least 14 days prior to Visit 1.
• •6. Clinically significant laboratory abnormalities at Visit 1 that, in the opinion of the Investigator, would make the subject a poor candidate for the study.
• •7. History of, or current, severe, progressive or uncontrolled renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genitourinary (renal disease) or hematological disease, neurologic or cerebral disorders, infectious disease or coagulation disorders that, as determined by the Investigator, would preclude participation in and completion of study assessments.
• •8. History of, current or suspected systemic or cutaneous malignancy and /or lymphoproliferative disease, other than subjects with: a history of adequately treated and well healed and completely cleared non-melanoma skin cancers (basal or squamous cell carcinoma) treated successfully at least 1 year prior to study entry with no evidence of disease.
• •9. Evidence of active or latent bacterial (including tuberculosis) or viral infections at the time of enrollment or history of incompletely treated or untreated tuberculosis. Subjects who have completed therapy for latent tuberculosis may participate.
• •10. History of a serious local infection (e.g., cellulitis, abscess) or systemic infection including but not limited to a history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to Visit 2. Subjects on an antibiotic for a non-serious, acute local infection must complete the course prior to enrollment into the study.
• •11. Positive serological test for HIV(antibody), HCV (antibody), or HepB (HBsAg). Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months before study enrollment. Subjects with a history of frequent outbreaks of Herpes Simplex Virus (defined as 4 or more outbreaks a year).
• •12. Screening ECG findings of:
• •1. QTcF \>450msec for males or \>470msec for females.
• •2. Heart rate \< 45 or \> 100 beats/minutes (inclusive).
• •3. Rhythm disturbance other than sinus arrhythmia or ectopic supraventricular rhythm (ectopic atrial rhythm).
• •4. Conduction disturbance including PR \>240msec, pre-excitation (delta wave and PR \<120msec), second degree or higher AV block.
• •5. Acute or chronic signs of ischemia.
• •6. Left Bundle Branch Block.
• •7. Prior myocardial infarction.