Status:
RECRUITING
A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers
Lead Sponsor:
Antidote Therapeutics, Inc
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Conditions:
Thromboangiitis Obliterans (Buerger's Disease)
Eligibility:
All Genders
23-59 years
Phase:
PHASE1
Brief 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 A...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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 Criteria
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07215923
Start Date
October 1 2025
End Date
September 30 2026
Last Update
October 15 2025
Active Locations (1)
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1
Dr. Vince Clinical Research
Overland Park, Kansas, United States, 66212