Phase I clinical trial of exploratory study to evaluate the safety, tolerability, pharmacokinetics and biological effects of intravenous BT-114143 injectable in healthy subjects

The dynamic balance of coagulation and anticoagulation is an important physiological function to maintain normal blood circulation and prevent blood loss. Blood coagulation is a process in which the soluble fibrinogen in the plasma is converted to insoluble fibrin. In the meaning time, the fibrinolysis system is activated to prevent excessive fibrin polymerization and thrombosis. However, abnormally enhanced fibrinolysis or hyperfibrinolysis can lead to the rapid decomposition of blood clots formed by fibrin leading to massive hemorrhage and even death. Antifibrinolytic drugs inhibit fibrinolysis to achieve hemostasis by blocking conversion of plasminogen to plasmin. Tranexamic acid (TXA) has been widely used as an antifibrinolytic small-molecule drug since 1960s. However, TXA has low affinity for plasminogen, thus requiring large dosage to achieve efficacy with potential side effects in the central nervous system. Therefore, a new generation of antifibrinolytic drugs is needed to overcome the abovementioned weakness of TXA.

BT-114143 is a novel antifibrinolytic small-molecule compound developed by ScinnoHub Pharmaceutical Co., Ltd. approved for Phase I clinical trial in China to evaluate the safety, tolerability, pharmacokinetics and biological effects of intravenous BT-114143 injectable in healthy subjects.

1. Male and female, 18-55 years old (including 18 and 55 years old);

2. Bogy weight of greater than or equal to 50.0 kg for man and 45.0 kg for women, respectively, and body mass index (BMI) within the range of 18.5~28 kg/square meter (including 18.5 and 28) [BMI=weight (kg)/square meter of height];

3. No eye color vision abnormalities, no history of abnormalities of heart, liver, kidney, digestive tract, nervous system, no history of mental disorders, metabolic syndromes and blood disorders.

Address: Address: Luzhong Hospital, Peking University Medical Center, No. 65, Taiji Road, Linzi District, Zibo City, Shandong Province, China