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

StatusRecruiting
PhasePhase 1
Started
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Record status
This record was last updated October 15, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary endpoints revised (2)v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07215923
Lead Sponsor Antidote Therapeutics, Inc
Collaborators: National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
Conditions
(from sponsor)		 Thromboangiitis Obliterans (Buerger's Disease)
Related terms Smoking Cessation, Smoking Reduction, Thromboangiitis Obliterans, Tobacco Use Disorder, Vascular Diseases
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov