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