A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers
Eligible age
23–59 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
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About this study
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.
Sponsor: Antidote Therapeutics, Inc
You may qualify if…
- ✓ 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 days prior to Screening through 90 days after dosing
You may not qualify if…
- ✕ 1. Pregnant, breastfeeding, or planning pregnancy
- ✕ 2. Positive serum pregnancy test at Screening or urine pregnancy test on Day -2 (women only)
- ✕ 3. Prior exposure to any anti-nicotine vaccine or antibody
- ✕ 4. Use of mentholated tobacco products within 30 days before Screening, unwilling to refrain during the study
- ✕ 5. History of severe allergic reaction to antibodies or vaccines (including Guillain-Barré syndrome)
- ✕ 6. Received any vaccination within 90 days prior to Screening
- ✕ 7. Clinically significant allergic adverse reaction (seasonal allergies allowed)
- ✕ 8. Use of systemic steroids or immunomodulating drugs within 90 days (inhaled steroids allowed)
Where it's recruiting
Overland Park
Source: ClinicalTrials.gov · NCT07215923 · last updated 2025-10-15