SmokingPhase 1CESTONCT02521701
Safety and Efficacity of NFL101 as Tobacco Therapy
A Phase 1 study testing NFL101 in people with Smoking, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
This Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- NFL101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, 34298
About this study
Official title: Phase I Study Assessing Safety and Efficacity of NFL101 as Tobacco Therapy(CESTO)
This Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers.
Read the detailed description
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.
- Conditions
- Smoking
- Being tested
- NFL101
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NFL101Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: NFL101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of safety in smoking subjects.
to access safety of NFL 101
Measured: 1 year
Secondary outcomes (1)
to determine immunogenicity of NFL 101
Response rate as a mesure of efficacy of NFL 101 in smoking subjects.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne STOEBNER, Principal investigator, ICM Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521701
- Sponsor's protocol ID
- ICM2014/34
- Acronym
- CESTO
- Status last verified
- Aug 2017
- First submitted
- 3 Mar 2015
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Assessing Safety and Efficacity of NFL101 as Tobacco Therapy(CESTO)
- ClinicalTrials.gov ID
- NCT02521701
- Acronym / sponsor ID
- CESTO / ICM2014/34
- Conditions
- Smoking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NFL101 | Experimental | Drug: NFL101Level 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (11 listed)
- Pregnancy and breastfeeding
- Concomitant participation to another clinical trial
- Concomitant active infectious diseases
- Concomitant desensitization therapy
- History of asthma or immune disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NFL101Level 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 |
Primary outcome
Number of Participants with Adverse Events as a Measure of safety in smoking subjects.
Time frame: 1 year
to access safety of NFL 101
1 secondary outcome
to determine immunogenicity of NFL 101
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne STOEBNER principal investigator
ICM Co. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NFL101 in people with Smoking, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of safety in smoking subjects. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.