Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC in Healthy Adult Volunteers

Phase 1 Completed 64 enrolled ZZ Biotech, LLC

RandomizedParallel-groupDouble-blindOther

Summary

The purpose of this study is to evaluate the safety and pharmacokinetic profile of single and multiple ascending intravenous doses of 3K3A-APC in healthy adult subjects aged 18-55 years.

Timeline

Start: 2012-08
Primary completion: 2012-12
Completion: 2012-12

Publications

Lyden P, Levy H, Weymer S, Pryor K, Kramer W, Griffin JH, Davis TP, Zlokovic B. Phase 1 safety, tolerability and pharmacokinetics of 3K3A-APC in healthy adult volunteers. Curr Pharm Des. 2013;19(42):7479-85. doi: 10.2174/1381612819666131230131454.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	3K3A-APC	Protein / enzyme biologic	6 ug/kg	Intravenous
Comparator	3K3A-APC	Protein / enzyme biologic	30 ug/kg	Intravenous
Comparator	3K3A-APC	Protein / enzyme biologic	90 ug/kg	Intravenous
Comparator	3K3A-APC	Protein / enzyme biologic	180 ug/kg	Intravenous
Comparator	3K3A-APC	Protein / enzyme biologic	360 ug/kg	Intravenous
Comparator	3K3A-APC	Protein / enzyme biologic	540 ug/kg	Intravenous
Comparator	3K3A-APC	Protein / enzyme biologic	720 ug/kg	Intravenous

Indications

No indication recorded.