Open label, non-randomized, uncontrolled, First-in-Human Phase 1 Study in Healthy Subjects and Subjects with Atopic Dermatitis

Key inclusion Criteria for Healthy Subjects (Part A)

• Written informed consent
• Able to communicate well with the investigator to understand and comply with the requirements of the study, including skin biopsies
• Healthy male and female subjects aged ≥18 and ≤ 65 years
• Able to comply with requirement of domiciliation at the investigational site

Key Exclusion Criteria for Healthy Subjects (Part A)

• Subjects with a history of hypertrophic scars or keloids.
• Any infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals and/or hospitalization, isolation, quarantine within 4 weeks prior to first treatment
• Women of childbearing potential defined as all women physiologically capable of becoming pregnant.
• History of drug or alcohol abuse within the 12 months prior to dosing

Key inclusion Criteria for Atopic Dermatitis Subjects (Part B)

• Written informed consent
• Able to communicate well with the investigator to understand and comply with the requirements of the study, including skin biopsies
• Adult male or female subjects aged ≥18 and ≤ 65 years with confirmed clinical diagnosis of atopic dermatitis (AD)

Key Exclusion Criteria Atopic Dermatitis Subjects (Part B)

• Subjects with a history of hypertrophic scars or keloids.
• Any infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals and/or hospitalization, isolation, quarantine within 4 weeks prior to first treatment
• Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
• History of drug or alcohol abuse within the 3 months prior to dosing
• Any skin disease that, in the opinion of the investigator, would confound the diagnosis or evaluation of AD disease activity
• Clinical significant medical condition, including psychiatric condition, which in the Investigator's opinion may interfere with safety of subjects, study objectives or adherence to the protocol.

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Open Label Study