Evaluation of Safety, PK and Immunomodulatory Effects of AB103 in Necrotizing Soft Tissue Infections Patients

Necrotizing Soft Tissue Infections Clinical Trial

Official title: Evaluation of Safety, Pharmacokinetics and Immunomodulatory Effects of AB103, a CD28 Co-stimulatory Receptor Antagonist, in Patients Diagnosed With Necrotizing Soft Tissue Infections

Status Completed

Clinical Trial Summary

A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care.

Clinical Trial Description

A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. The primary study hypothesis is that AB-103 can be administered safely to the patients presenting with Necrotizing Soft Tissue Infections.

Secondary endpoints are efficacy by exploratory descriptive analyses of specific efficacy endpoints from three outcome domains to demonstrate treatment benefit of AB103 in comparison to placebo in patients with Necrotizing Soft Tissue Infections. The efficacy domains are:

1. Clinical status domain

2. Pharmacoeconomics domain

3. Systemic and local inflammatory biomarker domain ;

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Necrotizing Soft Tissue Infections
• Soft Tissue Infections

• NCT number: NCT01417780
• Study type: Interventional
• Source: Atox Bio Ltd
• Status: Completed
• Phase: Phase 2
• Start date: December 2011
• Completion date: September 2012