A First-in-Human Study of CEE321 in Adult Subjects

• Status: Completed
• Trial end date: 2021-05-16
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.