A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers
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
15 participants
Oct 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria15
- 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
- Approximately 42 hours from evening of Day -1
Exclusion Criteria26
- Pregnant, breastfeeding, or planning pregnancy
- Positive serum pregnancy test at Screening or urine pregnancy test on Day -2 (women only)
- Prior exposure to any anti-nicotine vaccine or antibody
- Use of mentholated tobacco products within 30 days before Screening, unwilling to refrain during the study
- History of severe allergic reaction to antibodies or vaccines (including Guillain-Barré syndrome)
- Received any vaccination within 90 days prior to Screening
- Clinically significant allergic adverse reaction (seasonal allergies allowed)
- Use of systemic steroids or immunomodulating drugs within 90 days (inhaled steroids allowed)
- History of cancer (except treated basal/squamous cell skin cancer), HIV, other immunodeficiency, or autoimmune disease
- History of drug (excluding nicotine) or alcohol use disorder (DSM-5 criteria)
- Clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or psychiatric disorder, as determined by the Investigator
- Clinically significant abnormal clinical chemistry, hematology, or urinalysis at Screening or Day -2, in the opinion of the Investigator
- COVID-19 within the past 6 months or ongoing symptoms likely attributable to COVID-19
- 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
- Received an investigational product within 30 days (90 days for biologics) or 5 half-lives (whichever is longer) prior to Screening
- Exhaled carbon monoxide (CO) \<8 ppm at Screening
- Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody at Screening
- Positive urine alcohol test at Screening and/or Day -2
- Positive urine drug test (e.g., cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids) at Screening and/or Day -2
- Unwilling to abstain from xanthine-containing products (coffee, tea, cola, chocolate, energy drinks) within 24 hours prior to admission until discharge
- Unwilling to abstain from alcohol or alcohol-containing products within 24 hours prior to admission until discharge
- Significant blood donation or blood loss \>500 mL within 56 days before Screening
- Plasma donation or loss within 30 days prior to Screening through Day 84
- Hypersensitivity to the study drug, its excipients, or similar products
- Unable or unwilling to comply with protocol requirements, restrictions, or instructions
- Currently enrolled in another clinical study
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Interventions
Single intravenous (IV) infusion of ATI-1013, 0.2 g total dose.
Single IV infusion of ATI-1013, 0.8 g total dose.
Single IV infusion of ATI-1013, 3.2 g total dose.
Matching placebo (vehicle) IV infusion.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07215923