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
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.
• 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
• Female participants of non-childbearing potential must be surgically sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (≥1 year without menses)
⁃ Male participants must agree to use contraception and not donate sperm for 90 days after dosing
⁃ Willing to abstain from all other tobacco products from Day -2 through Day 84
⁃ Willing to abstain from all other nicotine products from Day -2 through Day 84
⁃ Willing to abstain from smoking regular cigarettes:
‣ Approximately 18 hours from evening of Day -2