Clinical Trial Finder

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 days prior to Screening through 90 days after dosing. 9. Female participants of non-childbearing potential must be surgically sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (≥1 year without menses) 10. Male participants must agree to use contraception and not donate sperm for 90 days after dosing. 11. Willing to abstain from all other tobacco products from Day -2 through Day 84. 12. Willing to abstain from all other nicotine products from Day -2 through Day 84. 13. Willing to abstain from smoking regular cigarettes: 1. Approximately 18 hours from evening of Day -2. 2. Approximately 42 hours from evening of Day -1.Exclusion Criteria. 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) 9. History of cancer (except treated basal/squamous cell skin cancer), HIV, other immunodeficiency, or autoimmune disease. 10. History of drug (excluding nicotine) or alcohol use disorder (DSM-5 criteria) 11. Clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or psychiatric disorder, as determined by the Investigator. 12. Clinically significant abnormal clinical chemistry, hematology, or urinalysis at Screening or Day -2, in the opinion of the Investigator. 13. COVID-19 within the past 6 months or ongoing symptoms likely attributable to COVID-19. 14. Use of varenicline, bupropion, nicotine replacement therapy (NRT), or other anti-smoking pharmacologic treatments (including off-label nortriptyline, clonidine, or cytisinicline) within 90 days prior to Screening. 15. Received an investigational product within 30 days (90 days for biologics) or 5 half-lives (whichever is longer) prior to Screening. 16. Exhaled carbon monoxide (CO) <8 ppm at Screening. 17. Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody at Screening. 18. Positive urine alcohol test at Screening and/or Day -2. 19. Positive urine drug test (e.g., cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids) at Screening and/or Day -2. 20. Unwilling to abstain from xanthine-containing products (coffee, tea, cola, chocolate, energy drinks) within 24 hours prior to admission until discharge. 21. Unwilling to abstain from alcohol or alcohol-containing products within 24 hours prior to admission until discharge. 22. Significant blood donation or blood loss >500 mL within 56 days before Screening. 23. Plasma donation or loss within 30 days prior to Screening through Day 84. 24. Hypersensitivity to the study drug, its excipients, or similar products. 25. Unable or unwilling to comply with protocol requirements, restrictions, or instructions. 26. Currently enrolled in another clinical study

Arms

Experimental: ATI-1013 (0.2 g)

Single-ascending-dose Cohort 1. Participants receive a single intravenous (IV) infusion of ATI-1013 0.2 g on Day 1. Randomization within the cohort is 4:1 (ATI-1013:placebo).

Experimental: ATI-1013 (0.8 g)

Single-ascending-dose Cohort 2. Participants receive a single IV infusion of ATI-1013 0.8 g on Day 1. Randomization 4:1 (ATI-1013:placebo).

Experimental: ATI-1013 (3.2 g)

Single-ascending-dose Cohort 3. Participants receive a single IV infusion of ATI-1013 3.2 g on Day 1. Randomization 4:1 (ATI-1013:placebo).

Interventions

Biological: - ATI-1013 (0.2 g)

Single intravenous (IV) infusion of ATI-1013, 0.2 g total dose.

Biological: - ATI-1013 (0.8 g)

Single IV infusion of ATI-1013, 0.8 g total dose.

Biological: - ATI-1013 (3.2 g)

Single IV infusion of ATI-1013, 3.2 g total dose.

Other: - Placebo

Matching placebo (vehicle) IV infusion.