Is NCT07215923 recruiting in Overland Park, KS?

Yes, NCT07215923 is currently recruiting participants at its Overland Park, KS location. This thromboangiitis obliterans (buerger's disease) clinical trial is actively enrolling qualified participants.

Is participation in this Overland Park clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Thromboangiitis Obliterans (Buerger's Disease) Clinical Trial in Overland Park, KS

Q: How do I join the thromboangiitis obliterans (buerger's disease) clinical trial in Overland Park?

To join this clinical trial in Overland Park, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Thromboangiitis Obliterans (Buerger's Disease) Study in Overland Park

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.

Sponsor: Antidote Therapeutics, Inc

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Overland Park?

Yes, this clinical trial (NCT07215923) has an active research site in Overland Park, KS that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Thromboangiitis Obliterans (Buerger's Disease) Treatment Options in Overland Park, KS

If you're searching for thromboangiitis obliterans (buerger's disease) treatment options in Overland Park, KS, this clinical trial (NCT07215923) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Overland Park research site is actively enrolling participants for this clinical trial. You'll receive care from experienced thromboangiitis obliterans (buerger's disease) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all thromboangiitis obliterans (buerger's disease) clinical trials near you to find additional studies recruiting in your area.

Thromboangiitis Obliterans (Buerger's Disease) Clinical Trial in Overland Park, KS

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