NCT06025552CompletedPhase 1
Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects
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
Source: ClinicalTrials.gov · Last updated 27 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 31 Jul 2023
- Start date
- Aug 2023
- Primary completion date
- Aug 2024
- Lead sponsor
- TiumBio Co., Ltd.
- Diseases
- Haemophilia
- NCT number
- NCT06025552
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 40
- From Aug 2023 to the primary completion date, Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently smoking or have smoked within 1 month before IP or positive cotinine results
- Excessive caffeine intake within 7 days before IP
Other illness
- 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)
- 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.
- History of alcohol abuse or positive alcohol breath test
- History of hypersensitivity to medicinal product similar to TU7710 active ingredient or excipient
- 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)
Lab values
- Abnormal coagulation related laboratory abnormal test results, including protein C, protein S, PT, aPTT
- INR results not between 2.0\~3.0 range after warfarin treatment
- 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
Who the study is looking for
- 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.
Age in the registry: 19 years to 45 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.