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NEO6860 is a novel antagonist of the activation of TRPV1 receptor by capsaicin, but not by heat or pH (modality selectivity). Hypothesis is that this profile will translate into a powerful analgesic without the adverse events (AEs) seen with previous TRPV1 antagonists (hyperthermia and reduced heat pain threshold). The objectives of this phase I study were to determine the safety, pharmacokinetic (including food and gender effect) and pharmacodynamic (PD, using capsaicin intra dermal capsaicin) profile of NEO6860 in healthy subjects. Sixty-four subjects participated between February and July 2015, exploring 8 cohorts: 50, 100, 200, 400, 800, 1200 mg single dose plus 500 mg bid dose levels. Doses up to 800 mg were welltolerated. 1200 mg dose was moderately tolerated mainly due to gastrointestinal events. Despite thorough monitoring, none of the AEs seen with previous TRPV1 were observed with NEO6860 …