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news.Nuvelo has announced positive results from the Phase I proof-of-concept trial of NU172, demonstrating that the thrombin-inhibitor achieved rapid onset and offset of anticoagulation after a single bolus dose with a favorable safety profile.
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The single-center, Phase I trial examined the safety, tolerability and pharmacokinetics of escalating bolus doses of NU172 in normal, healthy volunteers. In the trial, NU172 produced dose-dependent increases in anticoagulation, measured by activated clotting time (ACT). The 2mg/kg bolus dose of NU172 achieved target ACTs of approximately 400 seconds. Upon withdrawal of NU172 the ACT showed a rapid return toward baseline with a plasma half-life of NU172 of approximately 10 minutes. No serious adverse events occurred in the trial.
Ted Love, chairman and CEO of Nuvelo, said: “We plan to launch a Phase Ib trial of bolus dosing followed by escalating infusion doses of NU172 later this quarter, which should enable us to quickly begin a Phase II study evaluating NU172 in medical or surgical procedures in the fourth quarter of 2008 or the first quarter of 2009.”