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CEE321

Phase 1

Atopic Dermatitis | Small molecule | Dermatology |Novartis AG|Last Updated: Oct 28, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

CEE321 · 1 trial · 1 indication

Phase 1 1
NCT04612062A First-in-Human Study of CEE321 in Adult SubjectsAtopic Dermatitis
COMPLETED28 Analytics
PHASE1COMPLETED
A First-in-Human Study of CEE321 in Adult Subjects
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of subjects with adverse events
adverse events recorded during study

Secondary Endpoints

Plasma trough concentration of CEE321
day 15
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Healthy Subjects (Part A)EXPERIMENTALCEE321 0.2% (3 mg/cm2) topical cream b.i.d.
Atopic Dermatitis (Part B)EXPERIMENTALCEE321 0.2% (3 mg/cm2) topical cream b.i.d.

Interventions

NameTypeDescription
CEE321DRUGCEE321 administered to all subjects
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

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 requ...

Countries:United StatesJapan
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Frequently asked questions about CEE321

What is CEE321 used for?

CEE321 is an investigational small molecule being developed for atopic dermatitis, a chronic inflammatory skin condition. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in adult subjects with atopic dermatitis.

Who makes CEE321?

CEE321 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the safety and tolerability of this investigational drug.

What phase is CEE321 in?

CEE321 is in Phase 1 clinical development. A first-in-human study has been completed, and the drug remains investigational. It has not received regulatory approval and is not yet available for clinical use outside of research settings.

What clinical trials is CEE321 in?

CEE321 has been studied in one clinical trial with the identifier NCT04612062, titled 'A First-in-Human Study of CEE321 in Adult Subjects.' This Phase 1 study enrolled 28 participants with atopic dermatitis and was conducted in the United States and Japan. The trial has been completed.

Is CEE321 FDA approved?

CEE321 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for atopic dermatitis. The completed first-in-human study was designed to evaluate safety and tolerability, but the drug has not yet demonstrated efficacy or received marketing authorization.