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news.Cara Therapeutics has completed Phase I clinical trial for its second-generation, peripherally acting kappa opioid agonist, CR845, under development for the treatment of acute and chronic pain.
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The Phase Ia single-center clinical trial evaluated the safety, tolerability, pharmacokinetic profile, and pharmacological activity of CR845 in a double-blind, randomized, placebo-controlled, single escalating intravenous dose study in 54 healthy male and female volunteers. CR845 was shown to be safe at all doses investigated, with no reports of serious side effects or adverse central nervous system activity.
The drug candidate was safe and well-tolerated after intravenous infusion, and resulted in plasma levels of CR845 expected to be associated with clinical analgesic activity. In addition, CR845 infusion triggered a quantitative endocrine biomarker of peripheral kappa opioid receptor activation at the lowest dose tested.
The company plans to advance its intravenous formulation of CR845 into Phase II trials later in 2008. Based on the demonstrated safety, tolerability, and bioactivity of this formulation in Phase I, Cara will continue to develop its oral formulation of CR845 for advancement into Phase I.