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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 Cain
Published 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.
Keyphrases
  • placebo controlled
  • double blind
  • clinical trial
  • phase ii
  • phase iii
  • open label
  • study protocol
  • phase ii study
  • smoking cessation
  • young adults
  • squamous cell carcinoma