ATI-1013 for Smoking Cessation

Overseen By Leslie OToole

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Antidote Therapeutics, Inc

Must not be taking: Steroids, Immunomodulators, Anti-smoking drugs

Disqualifiers: Pregnancy, Cancer, HIV, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 54

Duration: 1 day

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ATI-1013, to determine its safety and effectiveness in helping people quit smoking. Researchers aim to discover how long ATI-1013 remains in the body, whether it triggers any immune reactions, and how it affects nicotine levels. Participants will receive either ATI-1013 or a placebo (a harmless look-alike) and will be monitored for any effects. Individuals who have smoked at least 10 cigarettes a day for the past two years and have not stopped for more than six months may be suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use certain smoking cessation drugs or nicotine products before and during the study. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that ATI-1013 is likely to be safe for humans?

Research has shown that ATI-1013 underwent animal testing before human trials. In one study with rats, ATI-1013 was administered daily for 30 days alongside nicotine, and no safety issues related to the drug were found. This suggests the treatment might be well-tolerated.

Since ATI-1013 is in the early stages of human testing, researchers are still studying its safety in people. The goal is to determine its safety for humans and its effect on nicotine levels in the body. As this is the first time the drug is tested in humans, the focus is on understanding its mechanism in the body and any potential immune reactions.

This is a Phase 1 trial, which primarily aims to assess safety and tolerance. This phase helps gather initial information on how the human body processes the drug. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard smoking cessation treatments, which commonly involve nicotine replacement therapies, medications like varenicline or bupropion, ATI-1013 offers a novel approach with its unique delivery method. Researchers are excited about ATI-1013 because it is administered through a single intravenous infusion, potentially providing a more direct and immediate effect. This could mean quicker onset of action compared to oral medications. Additionally, ATI-1013 might work differently by targeting specific pathways in the brain associated with addiction, offering a fresh alternative for those who haven't had success with existing therapies.

What evidence suggests that ATI-1013 could be an effective treatment for smoking cessation?

Research has shown that ATI-1013 can significantly lower nicotine levels in the brain. One study found that ATI-1013 reduced these levels by up to 95% after repeated nicotine use. ATI-1013 attaches to nicotine, preventing it from reaching the brain and diminishing its effects. Unlike current treatments for quitting smoking, this method does not target nicotine receptors. These early results suggest that ATI-1013 might help reduce nicotine addiction, making it a promising option for smoking cessation. Participants in this trial will receive different doses of ATI-1013 to evaluate its effectiveness and safety in helping people quit smoking. ^{1 2 4 6 7}

Who Is on the Research Team?

Matthew Kalnik, PhD

Principal Investigator

Antidote Therapeutics, Inc

Are You a Good Fit for This Trial?

This trial is for healthy adult cigarette smokers who want to participate in a study testing the safety of a new drug, ATI-1013. Participants must be willing to receive an IV infusion and follow up with visits and telephone check-ins. Specific eligibility criteria are not provided.

Inclusion Criteria

Provides written informed consent before any study procedures

Body mass index (BMI) 18.5-29.9 kg/m² at Screening

In good health with no medically significant conditions, in the opinion of the Investigator

Exclusion Criteria

Pregnant, breastfeeding, or planning pregnancy

Positive serum pregnancy test at Screening or urine pregnancy test on Day -2 (women only)

History of severe allergic reaction to antibodies or vaccines (including Guillain-Barré syndrome)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3-4 weeks

1 visit (in-person)

Treatment

Participants receive a single intravenous infusion of ATI-1013 or placebo and are monitored for immediate effects

1 day

In-clinic stay for at least 48 hours post-dose

Follow-up

Participants are monitored for safety, pharmacokinetics, and immune response through follow-up visits and telephone check-ins

12 weeks

5 visits (in-person), 4 check-ins (telephone)

What Are the Treatments Tested in This Trial?

Interventions

• ATI-1013

Trial Overview The trial is testing different doses of ATI-1013 (0.2 g, 0.8 g, 3.2 g) against a placebo to assess its safety, how long it stays in the body, if it triggers an immune response, and its effects on nicotine levels.

How Is the Trial Designed?

Group I: ATI-1013 (3.2 g) Experimental Treatment 2 Interventions

Single-ascending-dose Cohort 3. Participants receive a single IV infusion of ATI-1013 3.2 g on Day 1. Randomization 4:1 (ATI-1013:placebo).

Group II: ATI-1013 (0.8 g) Experimental Treatment 2 Interventions

Single-ascending-dose Cohort 2. Participants receive a single IV infusion of ATI-1013 0.8 g on Day 1. Randomization 4:1 (ATI-1013:placebo).

Group III: ATI-1013 (0.2 g) Experimental Treatment 2 Interventions

Single-ascending-dose Cohort 1. Participants receive a single intravenous (IV) infusion of ATI-1013 0.2 g on Day 1. Randomization within the cohort is 4:1 (ATI-1013:placebo).

Who Is Running the Clinical Trial?

Antidote Therapeutics, Inc

Lead Sponsor

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8323890/

Attenuating nicotine's effects with high affinity human anti ... Pretreatment with 40 and 80 mg/kg ATI-1013 reduced brain nicotine levels by 56 and 95%, respectively, in a repeated nicotine dosing experiment ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07215923?aggFilters=status%3A

A First in Human Single Ascending Dose (SAD) Study of ... This study is a first-in-human clinical trial of drug ATI-1013, in healthy adult cigarette smokers. The main questions it aims to answer are ...

3. researchgate.net researchgate.net/figure/ATI-1013-alters-nicotine-distribution-to-serum-and-brain-following-repeated_fig5_353594691

ATI-1013 alters nicotine distribution to serum and brain ... ATI-1013 alters nicotine distribution to serum and brain following repeated administration of nicotine Two groups of rats (n = 10/group) received ATI-1013 40 ...

4. reporter.nih.gov reporter.nih.gov/project-details/10695549

Monoclonal Antibody ATI-1013's MOA reduces nicotine exposure without acting on nicotinic receptors, offering a novel strategy compared to existing smoking cessation medications.

5. researchgate.net researchgate.net/publication/228089269_AAV-Directed_Persistent_Expression_of_a_Gene_Encoding_Anti-Nicotine_Antibody_for_Smoking_Cessation

AAV-Directed Persistent Expression of a Gene Encoding ... ATI-1013 was selected from a series of unique human-derived mAbs for its very high affinity for S-(-)-nicotine (K D = 2.4 nM by equilibrium ...

6. antidotetx.com antidotetx.com/pipeline/ATI-1013/

ATI-1013 | Anti-nicotine antibody When given to animals prior to a nicotine dose, ATI-1013 reduces entry of nicotine from the blood into the brain by more than 90%. This antibody-induced ...

7. hcplive.com hcplive.com/view/buergers-disease-treatment-ati1013-receives-orphan-drug-designation

Buergers Disease Treatment, ATI-1013, Receives Orphan ... A proprietary compound that neutralizes nicotine in the blood, ATI-1013 has been shown to block nicotine-induced increases in blood pressure, ...