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

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

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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: CEE321


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Subjects (Part A)<br>CEE321 0.2% (3 mg/cm2) topical cream b.i.d. | Drug: CEE321<br>* CEE321 administered to all subjects<br>* Other names: CEE321 0.2% (3 mg/cm2) topical cream b.i.d.;|
| Experimental: Atopic Dermatitis (Part B)<br>CEE321 0.2% (3 mg/cm2) topical cream b.i.d. | Drug: CEE321<br>* CEE321 administered to all subjects<br>* Other names: CEE321 0.2% (3 mg/cm2) topical cream b.i.d.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | adverse events recorded during study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma trough concentration of CEE321 |  | day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First-in-Human, Healthy Volunteers, Atopic Dermatitis, CEE321, Safety, Tolerability, Pharmacokinetics