The CYB004-E study is an adaptive, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics (“PK”) and pharmacodynamics (“PD”) of a target-controlled intravenous infusion of DMT in healthy smokers. Based on preclinical results reported by Cybin in April 2022, inhaled CYB004 demonstrated: approximately 2000% improved bioavailability compared with orally administered DMT, which is known to have limited to no oral bioavailability; approximately 41% improved bioavailability compared with inhaled DMT; approximately 300% longer duration of effect when compared with IV DMT, indicating potential to extend therapeutic window; and, rapid onset of effect and similar low variability equivalent to IV DMT.