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

A First-in-Human Study to Determine Safety, Tolerability and Systemic Exposure of Topically Applied CEE321 Cream in Adult Subjects

ClinicalTrials.gov Identifier: NCT04612062

Novartis Reference Number: CCEE321A12101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Atopic Dermatitis
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
28 participants
Start date 
Feb 27, 2020
Completion date 
Sep 16, 2021
Gender 
All
Age(s)
18 Years - 65 Years (Adult, Older Adult)

Interventions

Drug
CEE321
CEE321 administered to all subjects

Eligibility 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.

Study Locations

United States
Novartis Investigative Site
Recruiting
Glendale, 91206
California
United States
Novartis Investigator
Not yet recruiting
Baltimore, 21225
Maryland
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-888-669-6682 or email [email protected]