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

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

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: CEE321

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Hachioji, Tokyo, Japan, 192-0071
      • Novartis Investigative Site
• United States
  • California
    • Glendale, California, United States, 91206
      • Novartis Investigative Site
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Subjects (Part A); CEE321 0.2% (3 mg/cm2) topical cream b.i.d.	Drug: CEE321; CEE321 administered to all subjects; Other Names: CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
Experimental: Atopic Dermatitis (Part B); CEE321 0.2% (3 mg/cm2) topical cream b.i.d.	Drug: CEE321; CEE321 administered to all subjects; Other Names: CEE321 0.2% (3 mg/cm2) topical cream b.i.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with adverse events	adverse events recorded during study

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma trough concentration of CEE321	day 15

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• jRCT

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Actual): May 16, 2021
• Study Completion (Actual): May 16, 2021

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Safety; First-in-Human; Pharmacokinetics; Healthy Volunteers; Tolerability; Atopic Dermatitis; CEE321
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: CCEE321A12101; jRCT2031200317 (Other Identifier: jRCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No