NCT04895566

Phase 0/1 Local Application of the Monoclonal Antibody (Mab) sB24M in Patients With Purulent Pyoderma

Phase 0/1 Topical Application of the Monoclonal Antibody (Mab) sB24M in Patients With Severe Pyoderma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: SWISS BIOPHARMA MED GmbH · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pyoderma
• Pyoderma Gangrenosum
• Pyoderma Vegetans
• Pyoderma Gangrenosum Surrounding Surgical Stoma

Interventions

Type	Name	Description
BIOLOGICAL	Monoclonal antibody (Mab) sB24M	200 mg monoclonal antibody (Mab) sB24 by injection into the affected areas.

Timeline

• Start date: 2021-05-24
• Primary completion: 2023-03-10
• Completion: 2023-03-16
• First posted: 2021-05-20
• Last updated: 2023-03-20

Locations

2 sites across 2 countries: Belarus, Latvia