Actively Recruiting
A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers
Led by Antidote Therapeutics, Inc · Updated on 2025-10-15
15
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Antidote Therapeutics, Inc
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provides written informed consent before any study procedures
- Age 23 to 59 years, inclusive
- Body weight 50 kg or more at Screening
- Body mass index (BMI) 18.5-29.9 kg/m8 at Screening
- In good health with no medically significant conditions, according to the Investigator
- Current smoker, 10 or more cigarettes per day for 2 years or more, with no abstinence over 6 months
- Female participants must agree not to donate eggs during the study and for 90 days after dosing
- Female participants of childbearing potential must use an effective birth control method from 30 days before Screening through 90 days after dosing
- Female participants of non-childbearing potential must be surgically sterile or postmenopausal for at least 1 year
- 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 and approximately 42 hours from evening of Day -1
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy
- Positive pregnancy test at Screening or on Day -2 (women only)
- Prior exposure to any anti-nicotine vaccine or antibody
- Use of mentholated tobacco products within 30 days before Screening and unwilling to refrain during the study
- History of severe allergic reaction to antibodies or vaccines, including Guillain-Barr�e9 syndrome
- Vaccination within 90 days before Screening
- Clinically significant allergic reaction excluding seasonal allergies
- Use of systemic steroids or immunomodulating drugs within 90 days (inhaled steroids allowed)
- History of cancer (except treated skin cancer), HIV, immunodeficiency, or autoimmune disease
- History of drug or alcohol use disorder (excluding nicotine)
- Significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or psychiatric disorder
- Abnormal clinical tests at Screening or Day -2, per Investigator
- COVID-19 within past 6 months or ongoing symptoms
- Use of varenicline, bupropion, nicotine replacement therapy, or other anti-smoking drugs within 90 days
- Received an investigational product within 30 days (90 days for biologics) or 5 half-lives before Screening
- Exhaled carbon monoxide less than 8 ppm at Screening
- Positive tests for hepatitis B, hepatitis C, or HIV at Screening
- Positive urine alcohol or drug test at Screening or Day -2
- Unwilling to abstain from xanthine-containing products within 24 hours prior to admission until discharge
- Unwilling to abstain from alcohol within 24 hours prior to admission until discharge
- Significant blood or plasma donation within specified timeframes
- Hypersensitivity to the study drug or similar products
- Unable or unwilling to comply with protocol requirements
- Currently enrolled in another clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dr. Vince Clinical Research
Overland Park, Kansas, United States, 66212
Actively Recruiting
Research Team
L
Leslie OToole
CONTACT
A
Arjen DeVos, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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