Phase I Study Assessing Safety and Efficacity of NFL101 as Tobacco Therapy(CESTO)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of safety in smoking subjects.
研究概览
简要总结
This Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects ≥ 18 and ≤ 70 years old
- •ECOG/OMS performance status 0-1
- •Subjects currently smoking at least 11 cigarettes per day and with a dependency level ≥ 5 according to Fagerstöm scoring
- •Subjects willing to quit smoking
- •Good general health (i.e. no uncontrolled medical condition)
- •Good mental health (i.e. no alcohol or drug abuse in the past year, no psychiatric history- adequately treated depression is accepted).
- •For women of childbearing age: adequate contraception at least until 28 days after the second injection
- •French speaking
- •Patients must be affiliated to a social security system
- •Informed consent agreement and signature
排除标准
- •Pregnancy and breastfeeding
- •Concomitant participation to another clinical trial
- •Concomitant active infectious diseases
- •Concomitant desensitization therapy
- •History of asthma or immune disorders
- •History of any allergy including to nicotine or any components of study product
- •Uncontrolled diabetes
- •Use of corticosteroids, systemic steroids, antihistamines or immunosuppressive agents within 30 days prior to the study start
- •Prior exposure to a nicotine vaccine or to any other vaccine within 30 days before study product administration
- •Use of any therapy of smoking cessation within 90 days (including use of electronic cigarettes and alternative methods such as hypnosis or acupuncture)
- •Legal incapacity or physical, psychological or mental status interfering with the subject's ability to sign the informed consent or to terminate the study
研究组 & 干预措施
NFL101
Level 1: 100 µg
- 50 µg per injection (in each arm), two injections at day 1 and two injections at day 29
- The 140 µg must be diluted in 2.8 mL of dilution solution in order to obtain a 50 µg.mL-1 concentration.
Level 2: 200 µg
- 100 µg per injection (in each arm), two injections at day 1 and two injections at day 29
- The 140 µg must be diluted in 1.4 mL of dilution solution in order to obtain a 100 µg.mL-1 concentration. Therefore, for this level only, two vials are needed to inject 2 x 1.0 mL.
干预措施: NFL101 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of safety in smoking subjects.
时间窗: 1 year
to access safety of NFL 101
次要结局
- to determine immunogenicity of NFL 101(1 year)