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NCT07215923 · ClinicalTrials.gov registry record · Phase 1
A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers
A Phase 1 study of Thromboangiitis Obliterans (Buerger's Disease), sponsored by Antidote Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT07215923 is a Phase 1 study of Thromboangiitis Obliterans (Buerger's Disease) that is actively recruiting participants, run by Antidote Therapeutics. The registered enrollment target is 15 participants. The trial reports 1 study location across 1 state.
The verdict
NCT07215923, a Phase 1 study of Thromboangiitis Obliterans (Buerger's Disease), is actively recruiting participants, sponsored by Antidote Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- OTHER Placebo
- BIOLOGICAL ATI-1013 (0.2 g)
- BIOLOGICAL ATI-1013 (0.8 g)
- BIOLOGICAL ATI-1013 (3.2 g)
Study Locations (1)
Kansas
- Dr. Vince Clinical Research - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-10 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07215923
The ClinicalTrials.gov registry entry for NCT07215923 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Antidote Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Thromboangiitis Obliterans (Buerger's Disease) appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT07215923 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.
Frequently Asked Questions
What is clinical trial NCT07215923 about?
NCT07215923 is a clinical study titled "A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers". 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 d...
What is the current status of trial NCT07215923?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2025-10. Estimated completion is 2026-09-30.
What conditions does trial NCT07215923 study?
This clinical trial studies the following conditions: Thromboangiitis Obliterans (Buerger's Disease).
What interventions are being tested in trial NCT07215923?
The interventions under investigation include: Placebo (OTHER), ATI-1013 (0.2 g) (BIOLOGICAL), ATI-1013 (0.8 g) (BIOLOGICAL), ATI-1013 (3.2 g) (BIOLOGICAL).
Who is sponsoring clinical trial NCT07215923?
This trial is sponsored by Antidote Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07215923 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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