Cambridge, UK-based Acacia Pharma has initiated its first clinical trial, a Phase I study of its lead product candidate APD 405, which is being developed for the prevention and treatment of nausea and vomiting, a common problem after surgery and after therapy with many cancer chemotherapy drugs.
The clinical trial is a single, ascending-dose study of the safety, tolerability and pharmacokinetics of APD 405 in healthy volunteers. The trial will be exploring a range of six doses of APD 405 with six volunteers being enrolled at each dose level, one of whom will be randomized to receive a placebo.
According to the firm, the agent is an intravenous formulation of a drug that is already widely available in tablet form. The active ingredient within APD 405 targets two proven, complementary anti-emetic pathways. Acacia believes that this multifactorial approach could be of particular value in more difficult-to-treat patients, who often need more than one anti-emetic agent after surgery, or after highly emetogenic chemotherapy.
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