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Safety and efficacy of NFL-102 versus placebo for adults with tobacco dependence (Phase I/II)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on people who have Tobacco dependence and evaluates a new medication called NFL-102. Participants will receive either the study drug or a placebo, which looks the same but does not contain the active ingredient. The medication is given as a small shot under the skin, known as a subcutaneous injection.

The study’s purpose is to identify a dose of NFL-102 that is both safe and helps participants stop using tobacco. Volunteers will be assigned to one of several dose levels and will attend regular visits for about six weeks. During the visits, simple tests such as a urine test that measures nicotine breakdown products (urinary cotinine) and short questionnaires about cravings and smoking habits will be performed to see how well the drug works and whether any side effects occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Day 1 – Baseline Visit and First Injection

    You will attend the first on‑site visit on Day 1. During this visit a baseline assessment will be performed, including measurement of urinary cotinine, exhaled carbon monoxide (CO), cigarette consumption, and an electrocardiogram (ECG). You will also complete questionnaires about nicotine dependence, withdrawal symptoms, and craving.

    You will receive a single subcutaneous injection of the study medication. Depending on the randomisation, the injection will contain either NFL‑102 (the investigational drug) or a placebo consisting of sodium chloride solution. The exact amount of the drug is determined by the study protocol and will be administered at this visit.

    Blood will be drawn to evaluate safety laboratory values and to measure immune response (anti‑NFL‑102 antibodies). You will be observed for a short period after the injection for any immediate adverse reactions.

  2. Step 2

    Day 8 – Follow‑up Visit and Second Injection

    You will return to the clinic on Day 8 for a follow‑up visit. The same safety and efficacy assessments performed on Day 1 will be repeated: urinary cotinine, exhaled CO, cigarette count, ECG, and the questionnaires on dependence, withdrawal, and craving.

    A second subcutaneous injection will be administered. The injection will contain the same formulation (either NFL‑102 or placebo) as received on Day 1.

    Additional blood samples will be taken to monitor any new adverse events and to continue assessment of immunogenicity.

  3. Step 3

    Day 15 – Mid‑study Visit and Third Injection

    On Day 15 you will have a mid‑study visit. All previously described measurements (urinary cotinine, exhaled CO, cigarette consumption, ECG, and questionnaires) will be performed again.

    A third subcutaneous injection of the same study medication you received at earlier visits will be given.

    Safety monitoring will continue with blood tests and observation for any adverse events.

  4. Step 4

    Day 29 – Follow‑up Visit and Fourth Injection

    You will attend a follow‑up visit on Day 29. The study team will repeat the efficacy assessments (urinary cotinine, exhaled CO, cigarette consumption, ECG, and questionnaires).

    A fourth subcutaneous injection of the assigned medication (either NFL‑102 or placebo) will be administered.

    Blood will be drawn again to check safety parameters and immune response.

  5. Step 5

    Day 43 – End‑of‑Study Visit and Final Injection

    The final on‑site visit occurs on Day 43, which marks the end of the study period. All efficacy measurements (urinary cotinine, exhaled CO, cigarette consumption, ECG, and questionnaires) will be performed for the last time.

    A final subcutaneous injection of the study medication will be given, completing the dosing schedule.

    Comprehensive safety evaluations, including blood tests for adverse events and immunogenicity, will be completed. You will receive a summary of the study procedures you have completed.

Who can join the trial?

7 criteria

  • Be a man or woman who currently smokes tobacco cigarettes and is between 18 and 70 years old.
  • Smoke at least 11 cigarettes each day and have a nicotine addiction level of 3 or higher, as measured by the Fagerström Test for Nicotine Dependence (a questionnaire that rates how strong your smoking habit is).
  • Have a level of expired air carbon monoxide (CO) of 10 parts per million (ppm) or more, which means a measurable amount of smoke is still in your breath.
  • Be willing to try to quit smoking.
  • Be ready to make a quit attempt on the first day after receiving the study medication.
  • Have routine blood work and other health checks (called biological and hematological tests) and vital signs (such as blood pressure and heart rate) that are normal or not considered clinically significant (NCS) by the doctor.
  • Provide written consent agreeing to take part in the study.

Who cannot join the trial?

8 criteria

  • Pregnant or breastfeeding women – this means women who are expecting a baby or are feeding a baby with breast milk.
  • Known allergy to tobacco leaf – a reaction that causes symptoms like itching, rash, or trouble breathing when exposed to tobacco plant material.
  • Use of any smoking cessation therapy in the last 15 days or at the same time as the study – includes nicotine patches, gum, electronic cigarettes, hypnosis, acupuncture, or non‑nicotine cigarettes used to help quit smoking.
  • Participation in another clinical trial at the same time – being involved in a different research study while this one is happening.
  • Previous exposure to NFL‑101 or tobacco leaf extracts used for desensitization – having taken these specific medicines or extracts before to reduce sensitivity.
  • Having an active infectious disease, as judged by the doctor – a current illness caused by bacteria, viruses, or other germs that is still present.
  • Any uncontrolled medical condition – a health problem that is not being managed well or is unstable.
  • History or current alcohol abuse – past or ongoing excessive drinking that may affect health.
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Investigated drugs

NFL-102 is an experimental medication being studied as a new treatment to help people stop using tobacco and nicotine. In this trial, it is given as a small injection under the skin. The study is designed to first check that the medicine is safe and well‑tolerated at three increasing dose levels. After that, the researchers will choose the best two doses to test further and decide which dose works best for helping people quit smoking while still being safe.

What is already known about the treatment

  • Sodium Chloride

    It is given as a subcutaneous injection of a sterile solution. Sodium chloride is a well‑known electrolyte that is listed in standard medical references and is used worldwide. In this trial it serves only as a placebo and has no specific effect on tobacco dependence. It works by providing sodium and chloride ions that help keep the body’s fluid balance, and it is classified as an isotonic electrolyte solution.

  • NFL-102

    NFL‑102 is administered by subcutaneous injection as a clear solution for injection. It is an experimental drug that is currently only in Phase I/II clinical testing and is not yet approved for any use. The intended use is to help people stop using tobacco and nicotine. The product is designed to stimulate the immune system to make antibodies that bind nicotine, preventing it from reaching the brain, and it is classified as a nicotine‑targeted immunotherapy.

Investigated diseases

Tobacco dependence - A chronic condition in which a person feels a strong need to use tobacco products regularly. Over time, the body adapts to nicotine, leading to increased use to achieve the same effect. When use is reduced or stopped, the person experiences cravings and withdrawal symptoms that can drive a return to smoking. The pattern often worsens as tolerance grows, making it harder to quit without support.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2026-527266-77-00Protocol codeTONICEstimated enrolment310 patients

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