Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-26 @ 11:44 PM
Study NCT ID:
NCT04895566
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2021-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 0/1 Local Application of the Monoclonal Antibody (Mab) sB24M in Patients With Purulent Pyoderma
Sponsor:
SWISS BIOPHARMA MED GmbH
Organization:
Study Overview
Official Title:
Phase 0/1 Topical Application of the Monoclonal Antibody (Mab) sB24M in Patients With Severe Pyoderma
Status:
COMPLETED
Status Verified Date:
2023-03
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:
None
Brief Summary:
Phase 0/1 local application of the monoclonal antibody (Mab) sB24M in patients with purulent pyoderma (chronic ulcerative pyoderma) by injection into the affected areas.
Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.
Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.
Detailed Description:
This is an open-label Phase 0 trial that will enroll up to 10 participants with purulent pyoderma (chronic ulcerative pyoderma) by injecting 200 mg of the monoclonal antibody (Mab) sB24M into the areas affected by pyoderma.
Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.
This study is a first-in-man since previously no Clinical Studies on the local application (injections) of monoclonal antibodies in pyoderma gangrenosum have been conducted.
Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.
This study is a first-in-man since previously no Clinical Studies on the local application (injections) of monoclonal antibodies in pyoderma gangrenosum have been conducted.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: