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Completed

NCT Number: NCT04612062

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

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Hachiōji, Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CEE321

Drug

CEE321 administered to all subjects

Other names: CEE321 0.2% (3 mg/cm2) topical cream b.i.d.

Primary outcomes

  1. Number of subjects with adverse events

    Time frame: adverse events recorded during study

Secondary outcomes

  1. Plasma trough concentration of CEE321

    Time frame: day 15

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 2, 2020
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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