A Phase I, Double-blind, Randomized, Placebo-controlled, Single Dose-escalation Study to Evaluate the Tolerability and Safety of Cytisinicline in Adult Smokers.
Cindy JacobsMarlene FonsecaNancy A RigottiNeal L BenowitzAnthony ClarkeDan CainPublished in: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco (2022)
The cytisinicline therapeutic dose being evaluated in Phase 3 clinical trials is 3 mg, which is a 10fold lower dose than the 30 mg MTD level for cytisinicline, resulting in an excellent safety margin.