Phase I/II Clinical Study to Assess the Safety, Efficacy and Select the Dose of NFL-102 as a Tobacco and Nicotine Cessation Therapy (TONIC trial)

Who can take part

• Male or female tobacco smokers≥ 18 and ≤ 70-years-old
• Currently smoking at least 11 tobacco cigarettes per day with a dependency level ≥ 3 as determined by the Fagerström Test for Nicotine Dependence
• Whose expired air carbon monoxide (CO) is ≥10 ppm
• Willing to attempt to quit smoking
• Willing to make a quit attempt at D1 after the first product administration
• Routine biological and hematological tests and vital signs within the laboratory’s normal range or considered not clinically significant (NCS) by the investigator
• Having consented in writing for their participation in the study

Who cannot take part

• Prior (within previous 15 days) or concomitant use of any smoking cessation therapy (including nicotine patch and gum,electronic cigarettes and including alternative methods such as hypnosis or acupuncture or non-nicotinic cigarettes)
• Concurrent participation in another clinical trial
• Prior exposure to NFL-101 or tobacco leaf extracts used for desensitization
• Concomitant active infectious diseases as per investigator’s judgement
• Known allergy to tobacco leaf
• Any uncontrolled medical condition
• Pregnant and breastfeeding women
• History or presence of alcohol abuse