A Study to Assess the Safety, Tolerability, PK and PD of AM1030-CREAM in Patients With Atopic Dermatitis

AM1030: A Phase I/II, Double-Blind, Placebo-Controlled, Single and Multiple Ascending (Topical) Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Patients (Male and Female) With Atopic Dermatitis

This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of AM1030-CREAM in patients with Atopic Dermatitis.

Inclusion Criteria:

• Males and/or females of any ethnic origin between 18 and 65 years of age
• Body mass index between 18.0 and 35.0 kg/m2
• Subjects with AD as defined by the Hanifen and Rajka criteria and with mild to severe disease activity (IGA 2-4)
• AD lesions amenable to cutaneous treatment located on the trunk and/or limbs

Exclusion Criteria:

• Subjects with scars, moles, tattoos, sunburn or other blemishes in test areas
• Systemic treatment with immunosuppressants, immunomodulators or corticosteroids within 2 weeks prior to dosing
• Topical treatment with corticosteroids, antibiotics and/or immunomodulators within 4 days prior to dosing
• Treatment with systemic antihistamines within 24 hours of the first dose administration
• Treatment with SSRIs within 2 weeks of the first dose administration
• Subjects who have received phototherapy within 4 weeks prior to dosing