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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: Recruiting Phase 1 study of Thromboangiitis Obliterans (Buerger's Disease), sponsored by Antidote Therapeutics.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence of all adverse events (AEs), including infusion-related reactions (IRRs) and injection site reactions.
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 |
What NCT07215923 shows while recruiting
NCT07215923 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07215923's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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