What is ATI-1013 studying for smokers?

ATI-1013 is being studied to learn about its safety, how it stays in the body, and its effects on nicotine levels in healthy adult smokers. The research aims to understand if ATI-1013 triggers an immune response and how it compares to a placebo. This study is sponsored by Antidote Therapeutics, Inc.

Who may be eligible for this smoker clinical trial?

Adults aged 23 to 59 who are current smokers of at least 10 cigarettes daily for 2 years are eligible. Participants must be in good health and willing to avoid other tobacco or nicotine products during the study. Both men and women can join, with specific birth control requirements for women. Please review eligibility criteria for more details.

Is there any cost to participate in this smoker clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 1

Age: 23Years - 59Years

All Genders

Healthy Volunteers

ID07215923

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

Led by Antidote Therapeutics, Inc · Updated on 2025-10-15

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

This trial investigates ATI-1013, a drug being studied in healthy adult cigarette smokers to understand its safety, how long it stays in the body, whether it causes an immune response, and its effects on nicotine levels. The study compares ATI-1013 to a placebo to evaluate safety and how the drug interacts with nicotine. It is a first-in-human, phase 1 clinical trial conducted by Antidote Therapeutics, Inc. Participants receive one intravenous infusion of ATI-1013 at one of three escalating doses 0.2 g, 0.8 g, or 3.2 g or a placebo. The study uses a randomized, double-blind design with a 41 ratio favoring ATI-1013 in each dose group. The trial includes a screening period, a dosing day with at least 48 hours of in-clinic observation, and follow-up visits on Days 7, 21, 42, 56, and 84, plus telephone check-ins on Days 5, 14, 28, and 70. Participants keep a diary of their cigarette use and smoking habits. Researchers monitor adverse events, immune responses, and drug levels in the blood over 84 days. They also track nicotine-related physiological responses such as skin temperature, heart rate, blood pressure, and withdrawal symptoms, along with subjective effects of nicotine. Safety and drug behavior in the body are key outcomes throughout the study period.

CONDITIONS

Brief Title

A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers

Who Can Participate

Age: 23Years - 59Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Provides written informed consent before any study procedures
Age 23 to 59 years, inclusive
Body weight at least 50 kg at Screening
Body mass index (BMI) between 18.5 and 29.9 kg/m² at Screening
In good health with no medically significant conditions, as determined by the Investigator
Current smoker, at least 10 cigarettes per day for 2 or more years, with no abstinence over 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 effective birth control 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 and 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 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 reactions to antibodies or vaccines
Received any vaccination within 90 days prior to Screening
Clinically significant allergic adverse reactions (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, immunodeficiency, or autoimmune disease
History of drug or alcohol use disorder
Clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or psychiatric disorders
Abnormal clinical lab results at Screening or Day -2
COVID-19 infection within past 6 months or ongoing symptoms
Use of anti-smoking drugs within 90 days prior to Screening
Received investigational product within 30 days (90 days for biologics) prior to 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 and alcohol before admission until discharge
Recent significant blood or plasma donation
Hypersensitivity to the study drug or similar products
Unable or unwilling to follow study rules
Currently in another clinical study

Research Team

Leslie OToole

Arjen DeVos, MD

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