Study to Assess Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-level Deep Venous Thrombosis (DVT)

A Randomized Phase I/II Study to Assess the Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-Level Deep Venous Thrombosis

This study will evaluate the safety profile of GMI-1271 and its effect on thrombus resolution in patients with distal calf vein Deep Venous Thrombosis (DVT).

Inclusion Criteria:

• Age 18-75 years
• Male or female
• Diagnosed with acute isolated calf vein Deep Venous Thrombosis (DVT)
• Willing and able to participate in all required evaluations and procedures in this study protocol

Exclusion Criteria:

• History or presence of clinically significant medical condition or disease in the opinion of the principal investigator
• Uncontrolled acute life-threatening bacterial, viral or fungal infection
• Unable to be treated with systemic anticoagulants
• Current use of immunosuppressants, antiplatelets (other than aspirin), anticoagulants, and/or anti-epileptics
• Diagnosis of acute leukemia or multiple myeloma undergoing active treatment or maintenance treatment within the past 5 years
• Current or recent cancer treatment
• Major surgery within 21 days or planned surgery during the study period
• Female subjects who are pregnant or breastfeeding
• Known history of HIV, Hepatitis B or Hepatitis C
• Alcoholism or drug use
• Clinically significant cardiovascular disease