Clinical trial NCT04612062: A First-in-Human Study of CEE321 in Adult Subjects
Official title: A First-in-Human Study to Determine Safety, Tolerability and Systemic Exposure of Topically Applied CEE321 Cream in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: First-in-Human
Healthy Volunteers
Atopic Dermatitis
CEE321
Safety
Tolerability
Pharmacokinetics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-11-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a FIH study of CEE321 in Adult Healthy Subjects (Part A) and Subjects with Atopic Dermatitis (Part B).

Enrollment started with Healthy Subjects in Feb 2020. The protocol was amended Jul 2020 to include Atopic Dermatitis (AD) Subjects (Part B).
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: adverse events recorded during study
Secondary outcomes:
measure: Plasma trough concentration of CEE321
timeFrame: day 15
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Novartis Investigative Site
state: California
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Hachioji
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
References: