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

Novartis

Status and phase

Completed

Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: CEE321

Study type

Interventional

Funder types

Industry

Identifiers

jRCT2031200317 (Other Identifier)

CCEE321A12101

Details and patient eligibility

About

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

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.