ZZ Biotech, LLC has announced that it has commenced dosing healthy volunteers in a Phase 1 clinical study with 3K3A-APC, a recombinant variant of human activated protein C (APC), being developed for the treatment of acute ischemic stroke.
The Phase 1 study is a randomized, double-blind, placebo-controlled, single-center trial that will investigate the safety and pharmacokinetics of single and multiple ascending doses of 3K3A-APC in healthy adult volunteers.
Approximately 62 eligible adult subjects will be assigned sequentially to 1 of 10 cohorts, at successively higher single doses, followed by successively higher multiple doses. Results of the study are anticipated in the first quarter of 2013.
The foundation for 3K3A-APC was laid by scientific work conducted in laboratories at the University of Southern California and The Scripps Research Institute.
Dr. Kent Pryor, Chief Operating Officer of ZZ Biotech, commented: "We are very pleased to have received approval from The Austrian Agency for Health and Food Safety (AGES) to initiate our first human study with 3K3A-APC. Our extensive preclinical studies into the neuroprotective effects of 3K3A-APC suggest that it is a promising candidate for the treatment of ischemic stroke."
Mr. Joseph Romano, Chief Executive Officer of ZZ Biotech, added: "Stroke is the No. 4 cause of death and the leading cause of adult disability in the United States. We are excited by the prospect of one day putting 3K3A-APC in doctors' hands to help reduce the tremendous suffering caused by stroke."