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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04612062

Enrollment

Registered

2020-11-02

Start date

2020-02-27

Completion date

2021-05-16

Last updated

2022-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

First-in-Human, Healthy Volunteers, Atopic Dermatitis, CEE321, Safety, Tolerability, Pharmacokinetics

Brief summary

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

Interventions

DRUGCEE321

CEE321 administered to all subjects

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Masking description

Open Label Study

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).

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Number of subjects with adverse events	adverse events recorded during study

Secondary

Measure	Time frame
Plasma trough concentration of CEE321	day 15

Countries

Japan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026