Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects

The 40 subjects will be divided into 5 cohorts, and the subjects assigned to each cohort will be randomly assigned with 6 persons receiving TU7710 and 2 persons receiving a placebo for TU7710. Each cohort will proceed in sequence and the next cohort study will be decided by the Safety Monitoring Committee (SMC) .

Subjects will be participated in the study after warfarin anti-coagulation to maintain the INR between 2.00 and 3.00 as a preventive measure for potential thrombosis prior to the IP administration.

Inclusion criteria

• Age ≥19 and ≤45
• BMI of ≥18.0 kg/m2 and ≤30.0 kg/m2
• Body weight of ≥55.0 kg and ≤90.0 kg
• Provide informed consent and willing to comply with study requirements.

Exclusion criteria

• History or at risk of developing diseases related to venous thromboembolic events or has family history of such disease
• History of major bleeding/traumatic event or major surgery within 6 month
• History of any other clinically relevant coagulation disorder (such as gastrointestinal bleeding, hemorrhoid hemorrhage)
• Abnormal coagulation related laboratory abnormal test results, including protein C, protein S, PT, aPTT
• history or current symptoms of gastrointestinal, liver, or renal disease that may affect the pharmacokinetics of the IP
• History of or are currently with hepatitis B or C (active or carrier state) or human immunodeficiency virus (HIV) or syphilis infection.
• Currently smoking or have smoked within 1 month before IP or positive cotinine results
• History of alcohol abuse or positive alcohol breath test
• Excessive caffeine intake within 7 days before IP
• INR results not between 2.0~3.0 range after warfarin treatment
• History of hypersensitivity to medicinal product similar to TU7710 active ingredient or excipient
• Laboratory abnormal test results, such as QTcF <340msec or >450msec (or family history of long QT syndrome), LDL >190mg/dl , Total cholesterol >300mg/dl, triglycerides > 350mg/dl, ALT >1.5*ULN, AST >1.5*ULN, bilirubin >1.5*ULN
• Abnormal vital sign SBP >140mmHG, DBP <90mmHg, heart rate <40bpm or >85bpm
• Any medical history that may increase the risk or affect the evaluation of study objectives by participating in this study at the discretion of the investigator. (e.g., neurology or psychiatric history)