Safety, Tolerability, and PK of AN2728 in Adolescents With Atopic Dermatitis

Inclusion Criteria:

- Male or female 12 to 17 years of age, inclusive

- Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and
Rajka)

- AD in treatable areas (excludes the scalp and venous access areas) involving

≥10% and ≤35% of the total body surface area(BSA)

- Investigator's Static Global Assessment (ISGA) score of 2 or 3

- Normal or not clinically significant screening laboratory results

- Have adequate venous access to permit repeated PK sampling on Days 1 - 9 through
uninfected skin that has not been treated with study drug; each untreated venous
access area should provide a margin of at least 5 cm radius around the venipuncture
site

- Willing and able to comply with study instructions and commit to attending all visits

- Females must use a highly effective method of birth control.

- Parent/guardian has the ability to understand, agree to and sign the study Informed
Consent Form (ICF) prior to initiation of any protocol-related procedures; subject
has the ability to give assent

Exclusion Criteria:

- Significant confounding conditions as assessed by study doctor

- Unstable or actively infected AD

- Active or potentially recurrent dermatologic condition other than atopic dermatitis
that may confound evaluation

- History or evidence of allergies requiring acute or chronic treatment (except
seasonal allergic rhinitis)

- Concurrent or recent use of certain topical or systemic medications or phototherapy
without a sufficient washout period

- Treatment for any type of cancer (except squamous cell carcinoma, basal cell
carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or
surgical excision only) within the last 5 years

- Current pregnancy or lactation, or intent to become pregnant during the study

- Known sensitivity to any of the components of the study drug

- Participated in any other trial of an investigational drug or device within 30 days
or participation in a research study concurrent with this study

- Participated in a previous AN2728 clinical study