BridgeMD
New treatment option for Thromboangiitis Obliterans (Buerger's Disease)
Official title A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers
ClinicalTrials.gov ID: NCT07215923
What this study is testing
What is ATI-1013 (0.2 g)?
ATI-1013 (0.2 g) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for thromboangiitis obliterans (buerger's disease).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 23 to 59. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Overland Park, Kansas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 23 years to 59 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Overland Park, Kansas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.