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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04612062
• Other study ID #: CCEE321A12101
• Secondary ID: jRCT2031200317
• Status: Completed
• Phase: Phase 1
• Start date: February 27, 2020
• Est. completion date: May 16, 2021

Study information

• Verified date: October 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 16, 2021
• Est. primary completion date: May 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• CEE321
CEE321 administered to all subjects

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Hachioji	Tokyo
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events		adverse events recorded during study
Secondary	Plasma trough concentration of CEE321		day 15

External Links

•   jRCT