A First-in-Human (FIH), Randomized, Double-Blind, Placebo-controlled, Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of TU7710 Following Single, Ascending, Intravenous, Dose Administration in Warfarin Anti-coagulated Healthy Male Subjects

TUB4PI-01

This is a Phase 1a, double-blind, randomized, placebo- controlled, SAD study to assess safety, tolerability, PK, and PD of TU7710 in warfarin treated healthy male participants.

2023-08-02

2024-02-01

2024-02-01

Recruiting

Early phase I

40

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '5 cohorts with 5 dose levels will sequentially be escalated after safety review.\n\n8 subjects in each cohort who will be randomly assigned to placebo or TU7710 group in 2:6 ratio.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-09-11