A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers

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.

NCT Number	NCT07215923
Lead Sponsor	Antidote Therapeutics, Inc Collaborators: National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
Conditions	Thromboangiitis Obliterans (Buerger's Disease)
Enrollment	15 participants
Start Date	2025-10
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-10-15