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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 16, 2021

Interventions

  • Drug: CEE321
    • CEE321 administered to all subjects

Arms, Groups and Cohorts

  • Experimental: Healthy Subjects (Part A)
    • CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
  • Experimental: Atopic Dermatitis (Part B)
    • CEE321 0.2% (3 mg/cm2) topical cream b.i.d.

Clinical Trial Outcome Measures

Primary Measures

  • Number of subjects with adverse events
    • Time Frame: adverse events recorded during study

Secondary Measures

  • Plasma trough concentration of CEE321
    • Time Frame: day 15

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor

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