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

Conditions

• Thromboangiitis Obliterans (Buerger's Disease)

Eligibility Criteria

Sex

ALL

Age

23 Years - 59 Years

Healthy Volunteers

Accepted

Interventions

• ATI-1013 (0.2 g) — BIOLOGICAL
  Single intravenous (IV) infusion of ATI-1013, 0.2 g total dose.
• ATI-1013 (0.8 g) — BIOLOGICAL
  Single IV infusion of ATI-1013, 0.8 g total dose.
• ATI-1013 (3.2 g) — BIOLOGICAL
  Single IV infusion of ATI-1013, 3.2 g total dose.
• Placebo — OTHER
  Matching placebo (vehicle) IV infusion.

Study Details

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.

Key Dates

Start date

Oct 31, 2025

Status verified

Oct 2025

Primary completion

Jun 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

15 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ATI-1013 (0.2 g)
  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).
• Experimental: ATI-1013 (0.8 g)
  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).
• Experimental: ATI-1013 (3.2 g)
  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).

Primary Outcome Measure

Incidence of all adverse events (AEs) [ Time Frame: Day 1 through Day 84 ]

Central Contacts

• Leslie OToole
  412-352-3504
  [email protected]
• Arjen DeVos, MD
  443-994-3244

Locations (1)

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