A First-in-Human study of CEE321 in adult subjects

JRCT ID: jRCT2031200317

Registered date:20/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 21/01/2021
• Target sample size: 9
• Countries of recruitment: US,Japan
• Study type: Interventional
• Intervention(s): CEE321 (Topical use)

Outcome(s)

• Primary Outcome: Number of subjects with adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include 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 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 and female subjects aged >= 18 and =< 65 years with confirmed clinical diagnosis of atopic dermatitis (AD)

Exclude criteria

Key Exclustion 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 hispitalization, isolation, quarantine within 4 weeks prior to first treatment
- Women of childbearig potential defined as all women physiologically capabel of becoming pregnant.
- History of drug or alcohol abuse within the 12 months prior to dosing
Key Exclusion Criteria for 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 hispitalization, isolation, quarantine within 4 weeks prior to first treatment
- Women of childbearig potential defined as all women physiologically capabel of becoming pregnant, unless they are using highly effective methods of contraceptin
- 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 psychiaric condition, wihich in the Investigator's opinion may interfere with safety of subjects, study objectives or adherence to the protocol.

Related Information

• Primary Sponsor: Yamada Hiroyuki
• Secondary ID(s): NCT04612062