Thromboangiitis Obliterans (Buerger's Disease)Phase 1NCT07215923
A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers
A Phase 1 study testing ATI-1013 (0.2 g), ATI-1013 (0.8 g) and ATI-1013 (3.2 g) in people with Thromboangiitis Obliterans (Buerger's Disease), run by Antidote Therapeutics, Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 23 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Thromboangiitis Obliterans (Buerger's Disease)
- What is being tested?
- ATI-1013 (0.2 g), ATI-1013 (0.8 g) and ATI-1013 (3.2 g)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arjen DeVos, MD contact
United States1 site, 1 recruiting
- Recruiting
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
Collin Gerringer, 913-333-3000
About this study
Official title: 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
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.
- Being tested
- ATI-1013 (0.2 g), ATI-1013 (0.8 g), ATI-1013 (3.2 g), Placebo
- Keywords
- ATI-1013, Anti-nicotine monoclonal antibody, Nicotine dependence, Tobacco use disorder, Smoking cessation, Smoking reduction, Vascular disease, Phase 1, Healthy adult smokers
- Medical subject headings
- Thromboangiitis Obliterans, Tobacco Use Disorder, Smoking Cessation, Smoking Reduction, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI-1013 (0.2 g)Biological
Single intravenous (IV) infusion of ATI-1013, 0.2 g total dose.
ATI-1013 (0.8 g)Biological
Single IV infusion of ATI-1013, 0.8 g total dose.
ATI-1013 (3.2 g)Biological
Single IV infusion of ATI-1013, 3.2 g total dose.
PlaceboOther
Matching placebo (vehicle) IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| ATI-1013 (0.2 g) | Experimental | 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). Receives: Biological: ATI-1013 (0.2 g); Other: Placebo |
| ATI-1013 (0.8 g) | Experimental | 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). Receives: Biological: ATI-1013 (0.8 g); Other: Placebo |
| ATI-1013 (3.2 g) | Experimental | 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). Receives: Biological: ATI-1013 (3.2 g); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all adverse events (AEs)
Incidence of all adverse events (AEs), including infusion-related reactions (IRRs) and injection site reactions.
Measured: Day 1 through Day 84
Development of Anti-Drug Antibodies
Presence of anti-ATI-1013 antibodies following a single intravenous infusion.
Measured: Baseline (Day -1) through Day 84
Secondary outcomes (14)
Pharmacokinetics of ATI-1013 Maximum Concentration (Cmax)
Serum ATI-1013 maximum concentration.
Measured: Day 1 through Day 84
Pharmacokinetics of ATI-1013 Time to Maximum Concentration (Tmax)
Serum ATI-1013 time to maximum concentration.
Measured: Day 1 through Day 84
Pharmacokinetics of ATI-1013 Area Under the Curve (AUC)
Serum ATI-1013 area under the curve.
Measured: Day 1 through Day 84
Pharmacokinetics of ATI-1013 Half-life (t1/2)
Serum ATI-1013 half-life.
Measured: Day 1 through Day 84
Physiologic Responses to Nicotine (Skin Temperature)
Changes in physiologic responses to nicotine, including skin temperature (°F).
Measured: Day -1 and Day 2
Physiologic Responses to Nicotine (Heart Rate)
Changes in physiologic responses to nicotine, including heart rate (beats per minute).
Measured: Day -1 and Day 2
Physiologic Responses to Nicotine (Plasma Epinephrine)
Changes in physiologic responses to nicotine, including plasma epinephrine (picograms per milliliter (pg/mL)).
Measured: Day -1 and Day 2
Physiologic Responses to Nicotine (Blood Pressure)
Changes in physiologic responses to nicotine, including blood pressure (mmHg).
Measured: Day -1 and Day 2
Withdrawal Symptoms Minnesota Tobacco Withdrawal Scale (MTWS)
Self-reported withdrawal symptoms measured using the MTWS. (Minimum Value 0; Maximum Value 68; Higher score is a stronger withdrawal effect)
Measured: Day -1 and Day 2
Subjective/Psychological Effects of Nicotine Drug Effect Questionnaire (DEQ)
Self-reported subjective/psychological effects of nicotine using the DEQ (visual analogue scale from not at all to extremely, measure in millimeters; Higher score is a stronger effect of the cigarette).
Measured: Day -1 and Day 2
Subjective/Psychological Effects of Nicotine Modified Cigarette Evaluation Questionnaire (mCEQ)
Self-reported subjective/psychological effects of nicotine using the mCEQ (Minimum Value 12; Maximum Value 84; Higher score is a stronger addiction).
Measured: Day -1 and Day 2
Total Nicotine Levels
Blood concentrations of total nicotine.
Measured: Baseline through Day 84
Free Nicotine Levels
Blood concentrations of free nicotine.
Measured: Baseline through Day 84
ATI-1013-Bound Nicotine Levels
Blood concentrations of ATI-1013-bound nicotine.
Measured: Baseline through Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study startOct 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thromboangiitis Obliterans (Buerger's Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antidote Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Matthew Kalnik, PhD, Study chair, Antidote Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215923
- Sponsor's protocol ID
- ATI-1013-001
- Other IDs
- 5U01DA058547-03
- Status last verified
- Oct 2025
- First submitted
- 7 Oct 2025
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07215923
- Acronym / sponsor ID
- ATI-1013-001
- Keywords
- ATI-1013, Anti-nicotine monoclonal antibody, Nicotine dependence, Tobacco use disorder, Smoking cessation, Smoking reduction, Vascular disease, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Antidote Therapeutics, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Study start
- Oct 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ATI-1013 (0.2 g) | Experimental | Biological: ATI-1013 (0.2 g), Other: PlaceboSingle-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). |
| ATI-1013 (0.8 g) | Experimental | Biological: ATI-1013 (0.8 g), Other: PlaceboSingle-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). |
| ATI-1013 (3.2 g) | Experimental | Biological: ATI-1013 (3.2 g), Other: PlaceboSingle-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). |
Who may qualify
- Ages
- 23 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (26 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATI-1013 (0.2 g)Single intravenous (IV) infusion of ATI-1013, 0.2 g total dose. | Biological | ATI-1013 (0.2 g) |
| ATI-1013 (0.8 g)Single IV infusion of ATI-1013, 0.8 g total dose. | Biological | ATI-1013 (0.8 g) |
| ATI-1013 (3.2 g)Single IV infusion of ATI-1013, 3.2 g total dose. | Biological | ATI-1013 (3.2 g) |
| PlaceboMatching placebo (vehicle) IV infusion. | Other | ATI-1013 (0.2 g), ATI-1013 (0.8 g), ATI-1013 (3.2 g) |
Primary outcome
Incidence of all adverse events (AEs)
Time frame: Day 1 through Day 84
Incidence of all adverse events (AEs), including infusion-related reactions (IRRs) and injection site reactions.
Development of Anti-Drug Antibodies
Time frame: Baseline (Day -1) through Day 84
Presence of anti-ATI-1013 antibodies following a single intravenous infusion.
14 secondary outcomes
Pharmacokinetics of ATI-1013 Maximum Concentration (Cmax)
Time frame: Day 1 through Day 84
Pharmacokinetics of ATI-1013 Time to Maximum Concentration (Tmax)
Time frame: Day 1 through Day 84
Pharmacokinetics of ATI-1013 Area Under the Curve (AUC)
Time frame: Day 1 through Day 84
Pharmacokinetics of ATI-1013 Half-life (t1/2)
Time frame: Day 1 through Day 84
Physiologic Responses to Nicotine (Skin Temperature)
Time frame: Day -1 and Day 2
Physiologic Responses to Nicotine (Heart Rate)
Time frame: Day -1 and Day 2
Physiologic Responses to Nicotine (Plasma Epinephrine)
Time frame: Day -1 and Day 2
Physiologic Responses to Nicotine (Blood Pressure)
Time frame: Day -1 and Day 2
Withdrawal Symptoms Minnesota Tobacco Withdrawal Scale (MTWS)
Time frame: Day -1 and Day 2
Subjective/Psychological Effects of Nicotine Drug Effect Questionnaire (DEQ)
Time frame: Day -1 and Day 2
Subjective/Psychological Effects of Nicotine Modified Cigarette Evaluation Questionnaire (mCEQ)
Time frame: Day -1 and Day 2
Total Nicotine Levels
Time frame: Baseline through Day 84
Free Nicotine Levels
Time frame: Baseline through Day 84
ATI-1013-Bound Nicotine Levels
Time frame: Baseline through Day 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arjen DeVos, MD contact
Matthew Kalnik, PhD study chair
Antidote Therapeutics, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATI-1013 (0.2 g), ATI-1013 (0.8 g) and ATI-1013 (3.2 g) in people with Thromboangiitis Obliterans (Buerger's Disease), run by Antidote Therapeutics, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leslie OToole (412-352-3504, lotoole@antidotetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all adverse events (AEs) (time frame: Day 1 through Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.