A First in Human, Double-Blind, Placebo-Controlled, Randomized Evaluation of Single Ascending Doses of ATI-1013, a Human Monoclonal Antibody to Nicotine in Healthy Smokers
Antidote Therapeutics, Inc
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.
Eligibility
- Age range
- 23–59 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria 1. Provides written informed consent before any study procedures 2. Age 23 to 59 years, inclusive 3. Body weight ≥50 kg at Screening 4. Body mass index (BMI) 18.5-29.9 kg/m² at Screening 5. In good health with no medically significant conditions, in the opinion of the Investigator 6. Current smoker, ≥10 cigarettes per day for ≥2 years, with no abstinence \>6 months 7. Female participants must agree not to donate ova during the study and for 90 days after dosing 8. Female participants of childbearing potential must use an acceptable, effective method of birth control from 30…