Safety and Efficacity of NFL101 as Tobacco Therapy

NCT02521701 | Completed Phase 1

• 1 other identifier: ICM2014/34
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of safety in smoking subjects.

  to access safety of NFL 101

  1 year

Secondary Outcomes (1)

• to determine immunogenicity of NFL 101

  1 year

Study Arms (1)

NFL101

EXPERIMENTAL

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.

Drug: NFL101

Interventions

NFL101 DRUG

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.

NFL101

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Anne STOEBNER

  ICM Co. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: August 13, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: August 1, 2016
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

FR (1)