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news.Nuvelo has enrolled the first patient in a single-center, Phase Ib trial to determine the safety, tolerability and pharmacokinetics of bolus plus infusion dosing of NU172, a direct thrombin-inhibiting aptamer, in approximately 30 healthy male volunteers.
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Data from the single-center, Phase I trial showed that bolus doses of NU172 produced dose-dependent increases in anticoagulation, measured by activated clotting time (ACT). Upon discontinuation of NU172 the ACT showed a rapid return toward baseline with a plasma half-life of approximately 10 minutes.
Aptamers are chemically synthesized single-stranded nucleic acids that form well-defined three-dimensional shapes, allowing them to bind target molecules in a manner that is conceptually similar to antibodies.
Ted Love, chairman and CEO of Nuvelo, said: “This Phase Ib trial will study bolus dosing followed by escalating infusion doses of NU172 for up to four hours, mimicking the drug’s potential administration in coronary artery bypass graft surgery. We will complete this trial in the third quarter of 2008 and anticipate moving forward with a Phase II study in the fourth quarter of 2008 or the first quarter of 2009.”