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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CEE321
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring First-in-Human, Healthy Volunteers, Atopic Dermatitis, CEE321, Safety, Tolerability, Pharmacokinetics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy Subjects (Part A)

Atopic Dermatitis (Part B)

Arm Description

CEE321 0.2% (3 mg/cm2) topical cream b.i.d.

CEE321 0.2% (3 mg/cm2) topical cream b.i.d.

Outcomes

Primary Outcome Measures

Number of subjects with adverse events

Secondary Outcome Measures

Plasma trough concentration of CEE321

Full Information

First Posted
October 27, 2020
Last Updated
October 26, 2022
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04612062
Brief Title
A First-in-Human Study of CEE321 in Adult Subjects
Official Title
A First-in-Human Study to Determine Safety, Tolerability and Systemic Exposure of Topically Applied CEE321 Cream in Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
May 16, 2021 (Actual)
Study Completion Date
May 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
First-in-Human, Healthy Volunteers, Atopic Dermatitis, CEE321, Safety, Tolerability, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
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).
Masking
None (Open Label)
Masking Description
Open Label Study
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Subjects (Part A)
Arm Type
Experimental
Arm Description
CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
Arm Title
Atopic Dermatitis (Part B)
Arm Type
Experimental
Arm Description
CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
Intervention Type
Drug
Intervention Name(s)
CEE321
Other Intervention Name(s)
CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
Intervention Description
CEE321 administered to all subjects
Primary Outcome Measure Information:
Title
Number of subjects with adverse events
Time Frame
adverse events recorded during study
Secondary Outcome Measure Information:
Title
Plasma trough concentration of CEE321
Time Frame
day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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.
Facility Information:
Facility Name
Novartis Investigative Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Novartis Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Novartis Investigative Site
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0071
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Links:
URL
https://jrct.niph.go.jp/en-latest-detail/jRCT2031200317
Description
jRCT

Learn more about this trial

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

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