A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers (NCT07215923) | Clinical Trial Compass
RecruitingPhase 1
A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers
United States15 participantsStarted 2025-10
Plain-language summary
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 to learn about the safety of drug ATI-1013, how long drug ATI-1013 remains within the body, does drug ATI-1013 trigger an immune response, and the effects of drug ATI-1013 on nicotine levels within the body.
The clinical trial will compare drug ATI-1013 to a placebo (a look-alike substance that contains no drug) to see if drug ATI-1013 has comparable safety.
Participants will have a Screening visit (Day -28 to -3) and will be admitted on Day -2. Each participant will receive one intravenous (IV) infusion of ATI-1013 or placebo (Day 1). Participants will remain in-clinic for at least 48 hours post-dose and return for follow-up visits on Days 7, 21, 42, 56, and 84, with telephone check-ins on Days 5, 14, 28, and 70. Participants will keep a diary of their cigarette use and smoking behaviors.
Who can participate
Age range
23 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provides written informed consent before any study procedures
. Age 23 to 59 years, inclusive
. Body weight ≥50 kg at Screening
. 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
. Current smoker, ≥10 cigarettes per day for ≥2 years, with no abstinence \>6 months
. Female participants must agree not to donate ova during the study and for 90 days after dosing
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Female participants of childbearing potential must use an acceptable, effective method of birth control from 30 days prior to Screening through 90 days after dosing
Exclusion criteria
. Pregnant, breastfeeding, or planning pregnancy
. Positive serum pregnancy test at Screening or urine pregnancy test on Day -2 (women only)
. Prior exposure to any anti-nicotine vaccine or antibody
. Use of mentholated tobacco products within 30 days before Screening, unwilling to refrain during the study
. History of severe allergic reaction to antibodies or vaccines (including Guillain-Barré syndrome)
. Received any vaccination within 90 days prior to Screening