Safety and Tolerability Study of ZEP-3 Cream (0.1% and 1.0%), Administered Topically In Healthy Volunteers

The primary endpoints of this study are:

• Safety evaluation - To demonstrate ZEP-3 cream safety in terms of skin irritation score.
• Safety evaluation - To demonstrate ZEP-3 cream safety in terms of type and severity of reported adverse events.
• Tolerability evaluation - To demonstrate ZEP-3 cream tolerability in terms of treatment compliance by the treated volunteers.

The secondary endpoints of this study are:

• Systemic absorption PK profile.
• Dermal absorption PK profile (Optional).

Subject safety will be assessed following treatment by ZEP-3 cream, using measurements of the following variables:

• Dermal reaction parameters
• Physical examination
• Vital Signs (HR, BP, RR, Body temperature)
• 12 lead ECG data
• Laboratory tests (CBC, blood chemistry, coagulation functions, urinalysis)
• Adverse events recording
• Change in concomitant medications

Inclusion criteria

• Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
• Subject, either men or women is between 18 and 50 years of age.
• Subject, Body mass index (BMI) is within the normal to overweight range (See appendix 2)
• Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test article
• Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
• Subject is willing to participate in the study and adhere to the study protocol
• Females of childbearing potential should either be surgically sterile, or should use a highly effective medically accepted contraceptive regimen.

Exclusion criteria

• Subject has hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields
• Dark skinned persons whose skin color prevents ready assessment of skin reactions
• Subject with history of skin disorders or any active skin condition involving the test fields including but not limited to bacterial, viral, or fungal skin infections, acne, rosacea
• UV therapy or significant UV exposure in the four weeks before treatment application
• Subject with renal failure (Cr > 2 mg/dl) or Subject with impaired hepatic function (ALT, AST 2-fold higher than normal upper limit value).
• Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
• Subject suffers from an autoimmune disease (Diabetes, Lupus. Chron ect.)
• History of malignancy
• Sever illness or surgery within the previous 3 months (except for minor cosmetic or dental procedures)
• Treatment with any investigational agent in another clinical trial within 1 month prior to start of this study.
• Female subject who is pregnant , lactating, or with a positive pregnancy test
• History of drug or alcohol abuse (as defined by the Investigator)