Pharmos has initiated a Phase I trial of cannabinor, a CB2-selective synthetic
cannabinoid drug candidate. The study will assess the safety, tolerability and
pharmacokinetics of cannabinor in healthy volunteers.
The trial will enroll up to 48 healthy male subjects in a randomized, double-blind, placebo controlled, intravenous, escalating single dose study. The trial is being conducted at the Harrison Clinical Research Unit in Munich, Germany, with clinical trial material manufactured in the company's GMP pilot facility.
It is expected that the trial will be completed and the results analyzed by the end of the year. If the trial results demonstrate that an adequate dose is safe and well-tolerated, Phase II trials in pain indications will be planned for early 2006.