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

NCT07215923 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-10-15

No results posted yet for this study

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)

Interventions

BIOLOGICAL

ATI-1013 (0.2 g)

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

BIOLOGICAL

ATI-1013 (0.8 g)

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

BIOLOGICAL

ATI-1013 (3.2 g)

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

OTHER

Placebo

Matching placebo (vehicle) IV infusion.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Antidote Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Matthew Kalnik, PhD · Antidote Therapeutics, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
23 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-06-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215923 on ClinicalTrials.gov