Ignite Creation Date:
2024-07-17 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469385
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-17
Brief Title:
Topical ENS-002 for Atopic Dermatitis in Adults
Sponsor:
Concerto Biosciences
Organization:
Concerto Biosciences
Study Overview
Official Title:
Phase 1 First in Human Dose Escalation and Safety Study of Topical ENS-002 for Atopic Dermatitis in Adults
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EnSync
Brief Summary:
The goal of this study is to determine the safety and effects of ENS-002 a live biotherapeutic product LBP consisting of commensal clonal non-pathogenic bacteria in participants with atopic dermatitis
Detailed Description:
This is a Phase 1 open-label non-randomized study investigating ENS-002 a live biotherapeutic product LBP consisting of commensal clonal non-pathogenic bacteria
The purpose of this dose escalation study is to determine the recommended Phase 2 dose RP2D of ENS-002 in participants with mild to moderate atopic dermatitis
Participation in this study will continue until dose limiting toxicity or therapy intolerance or participant withdrawal
The purpose of this dose escalation study is to determine the recommended Phase 2 dose RP2D of ENS-002 in participants with mild to moderate atopic dermatitis
Participation in this study will continue until dose limiting toxicity or therapy intolerance or participant withdrawal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None