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CEE321

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04612062A First-in-Human Study of CEE321 in Adult SubjectsPHASE1 COMPLETED 28Feb 27, 2020May 16, 2021Oct 28, 20223 United States, Japan
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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 — 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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