ZZ Biotech Initiates Phase 1 Study with 3K3A-APC for the Treatment of Acute Ischemic Stroke
ZZ Biotech, LLC today 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.
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