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

PHASE1RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

September 30, 2026

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.

Trial Locations (1)

66212

RECRUITING

Dr. Vince Clinical Research, Overland Park

Sponsors
All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

Antidote Therapeutics, Inc

INDUSTRY

NCT07215923 - A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers | Biotech Hunter | Biotech Hunter