NCT04612062

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2020

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2021

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

October 27, 2020

Last Update Submit

October 26, 2022

Conditions

Atopic Dermatitis

Keywords

First-in-HumanHealthy VolunteersAtopic DermatitisCEE321SafetyTolerabilityPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with adverse events

    adverse events recorded during study

Secondary Outcomes (1)

  • Plasma trough concentration of CEE321

    day 15

Study Arms (2)

Healthy Subjects (Part A)

EXPERIMENTAL

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

Drug: CEE321

Atopic Dermatitis (Part B)

EXPERIMENTAL

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

Drug: CEE321

Interventions

CEE321DRUG

CEE321 administered to all subjects

Also known as: CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
Atopic Dermatitis (Part B)Healthy Subjects (Part A)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis Investigative Site

Glendale, California, 91206, United States

Location

Novartis Investigative Site

Baltimore, Maryland, 21225, United States

Location

Novartis Investigative Site

Hachiōji, Tokyo, 192-0071, Japan

Location

Related Links

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Open Label Study
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 2, 2020

Study Start

February 27, 2020

Primary Completion

May 16, 2021

Study Completion

May 16, 2021

Last Updated

October 28, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

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

Locations

US(2)JP(1)