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

NCT07215923 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: ATI-1013-0015U01DA058547-03
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Thromboangiitis Obliterans (Buerger's Disease)

Keywords

ATI-1013; Anti-nicotine monoclonal antibody; Nicotine dependence; Tobacco use disorder; Smoking cessation; Smoking reduction; Vascular disease; Phase 1; Healthy adult smokers

Outcome Measures

Primary Outcomes (2)

• Incidence of all adverse events (AEs)

  Incidence of all adverse events (AEs), including infusion-related reactions (IRRs) and injection site reactions.

  Day 1 through Day 84

• Development of Anti-Drug Antibodies

  Presence of anti-ATI-1013 antibodies following a single intravenous infusion.

  Baseline (Day -1) through Day 84

Secondary Outcomes (14)

• Pharmacokinetics of ATI-1013 Maximum Concentration (Cmax)

  Day 1 through Day 84

• Pharmacokinetics of ATI-1013 Time to Maximum Concentration (Tmax)

  Day 1 through Day 84

• Pharmacokinetics of ATI-1013 Area Under the Curve (AUC)

  Day 1 through Day 84

• Pharmacokinetics of ATI-1013 Half-life (t1/2)

  Day 1 through Day 84

• Physiologic Responses to Nicotine (Skin Temperature)

  Day -1 and Day 2

Study Arms (3)

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).

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).

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).

Biological: ATI-1013 (3.2 g); Other: Placebo

Interventions

ATI-1013 (0.2 g) BIOLOGICAL

Single intravenous (IV) infusion of ATI-1013, 0.2 g total dose.

ATI-1013 (0.2 g)

ATI-1013 (0.8 g) BIOLOGICAL

Single IV infusion of ATI-1013, 0.8 g total dose.

ATI-1013 (0.8 g)

ATI-1013 (3.2 g) BIOLOGICAL

Single IV infusion of ATI-1013, 3.2 g total dose.

ATI-1013 (3.2 g)

Placebo OTHER

Matching placebo (vehicle) IV infusion.

ATI-1013 (0.2 g); ATI-1013 (0.8 g); ATI-1013 (3.2 g)

Eligibility Criteria

• Age: 23 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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
• 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Antidote Therapeutics, Inc: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

RECRUITING

MeSH Terms

Conditions

Thromboangiitis Obliterans; Tobacco Use Disorder; Smoking Cessation; Smoking Reduction; Vascular Diseases

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Cardiovascular Diseases; Vasculitis; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Smoking

Study Officials

• Matthew Kalnik, PhD

  Antidote Therapeutics, Inc

  STUDY CHAIR

Central Study Contacts

Leslie OToole

CONTACT

412-352-3504; lotoole@antidotetx.com

Arjen DeVos, MD

CONTACT

443-994-3244

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2025
• First Posted: October 14, 2025
• Study Start: October 1, 2025
• Primary Completion: June 30, 2026
• Study Completion: September 30, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)