Status:
COMPLETED
Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects
Lead Sponsor:
TiumBio Co., Ltd.
Conditions:
Hemophilia a
Hemophilia B
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06025552
Start Date
August 2 2023
End Date
August 21 2024
Last Update
September 27 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea