Safety and Efficacity of NFL101 as Tobacco Therapy (CESTO)
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|ClinicalTrials.gov Identifier: NCT02521701|
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : August 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Drug: NFL101||Phase 1|
Tobacco addiction is one of the biggest public health threats the world has ever faced, killing nearly six million people a year. There are more than 1 billion smokers in the world, up to half will eventually die of a tobacco-related disease. Nicotine replacement treatments were the first pharmacological treatments approved for use in smoking cessation therapy and include nicotine gums, transdermal patches, tablets, nasal sprays, and inhalation systems. More recently, buproprion and varenicline were approved but showed limiting side effects. The development of safe and efficient alternatives for this indication is now called for.
Tobacco cessation cases were observed concomitantly with the administration of a desensitization treatment against tobacco allergy. Based on these observations, NFL Biosciences developed a drug candidate for tobacco cessation. This new drug (NFL 101) was assessed in preclinical studies. Notably, regulatory genotoxicity (Institut Pasteur de Lille) and toxicity studies in rats (Ricerca, Wil Research, Lyon) showed no toxicity. The NFL 101 composition and the low doses injected led to propose a mechanism of action based on an immune response. Immunogenicity studies conducted with the European Georges Pompidou Hospital (HEGP) on peripheral blood mononuclear cells and rodents have supported such hypotheses. Therefore, the objective of this Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study Assessing Safety and Efficacity of NFL101 as Tobacco Therapy(CESTO)|
|Actual Study Start Date :||December 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||August 2016|
Level 1: 100 µg
Level 2: 200 µg
Level 1: 100 µg
Level 2: 200 µg
- Number of Participants with Adverse Events as a Measure of safety in smoking subjects. [ Time Frame: 1 year ]to access safety of NFL 101
- to determine immunogenicity of NFL 101 [ Time Frame: 1 year ]Response rate as a mesure of efficacy of NFL 101 in smoking subjects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521701
|Institut du Cancer de Montpellier - Val d'Aurelle|
|Montpellier, France, 34298|
|Principal Investigator:||Anne STOEBNER||ICM Co. Ltd.|