Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects
Study Details
- Hemophilia A
- Hemophilia B
- Ignored
- Drug: TU7710
- Drug: Normal saline
- 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)
Protocol Summary
This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.