Safety and Efficacity of NFL101 as Tobacco Therapy

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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