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news.Neurogen Corporation has commenced phase II human testing of the company's leading drug candidate for insomnia, NG2-73.
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The phase II clinical trial is designed to determine the efficacy of four dose levels of NG2-73 compared to placebo in reducing the time it takes to fall asleep.
The study will be conducted at 12 sites in the US. Healthy adult subjects will be enrolled in five treatment arms totaling 360 subjects.
“This phase II trial is the first of a comprehensive plan that will build on the exciting results we have seen in phase I testing,” said William Koster, president and CEO. “In studies completed thus far NG2-73 appears to have a very attractive safety profile and we have observed consistent incidents of sleepiness.”
Neurogen previously announced results from a first-in-human, single ascending dose study and a multiple ascending dose study for NG2-73. In both phase I trials, the compound was safe and well-tolerated with no serious adverse events.