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 range23 Years – 59 Years
SexALL
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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
✓. 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)