The goal of this clinical trial is to evaluate the safety and efficacy of KN057 in adult patients with severe Hemophilia A (coagulation factor FVIII activity \<1%) or moderate-to-severe Hemophilia B (FIX activity ≤2%). Participants will be administered subcutaneously with KN057 once a week for 20 weeks. KN057 works differently than factor replacement products and will work in the presence of inhibitors. The potential for once weekly subcutaneous administration provides better convenience and compliance.
Male, 18-70 years old (including thresholds), body weight ≥40 kg and BMI <30 kg/m².
Severe Hemophilia A or moderate-to-severe Hemophilia B (coagulation factor FVIII activity <1% or FIX activity ≤2%).
Have ≥ 6 treated bleeding episodes within 24 weeks prior to screening (spontaneous and/or traumatic, excluding bleeding episodes related to surgery or traumatic operation).
Patients without inhibitors must meet the following criteria: FVIII or FIX inhibitor test is negative during the screening period. Use coagulation factor replacement therapy for no less than 100 exposure days before screening.
Those with serious or poorly controlled chronic diseases or obvious systemic diseases: such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, autoimmune diseases, neurological diseases or psychiatric diseases, bacterial or viral infection, etc.; have previously received lipid-lowering therapy for hypertriglyceridemia or are currently receiving lipid-lowering therapy for hypertriglyceridemia.
Have a history of other hereditary or acquired bleeding disorders other than Hemophilia A and Hemophilia B.
Have symptoms and signs related to thromboembolic disease or are receiving thrombolytic/antithrombotic treatment; have a history of coronary atherosclerotic disease, arterial or venous thrombosis, or ischemic disease of important organs.
Have high risk factors for thrombosis, including reduced activity of antithrombin III, protein S or protein C.
Single group
KN057
DrugKN057 will be administered subcutaneously once a week.
Incidence and severity of treatment emergent adverse events(TEAEs)
TEAEs are adverse events occurred following the start of treatment or adverse events increasing in severity during treatment.
Number of participants with abnormal laboratory findings in Hematology
Including white blood cells, red blood cells, lymphocyte count, neutrophil count, monocyte count, eosinophil count, basophil count, lymphocyte percentage, neutrophil percentage, monocyte percentage, eosinophil percentage, basophil percentage, hemoglobin, hematocrit, platelet count.
Number of participants with abnormal laboratory findings in Coagulation Function
Including prothrombin time (PT), international normalized ratio (INR), activated partial thrombin time (APTT), thrombin time (TT), fibrinogen (FBG/FIB), D-dimer (D-Di), fibrin(ogen) degradation product (FDP), antithrombin-Ⅲ (AT-Ⅲ)
Number of participants with abnormal laboratory findings in Blood Biochemistry
Including total bilirubin (TBIL), indirect bilirubin (IBIL), direct bilirubin (DBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), alkaline phosphatase (ALP), total protein (TP), albumin (ALB), globulin, white globulin ratio , urea and/or urea nitrogen (BUN) (collected according to the specific test item at the clinical site), creatinine (Cr), uric acid, glucose, total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), lactate dehydrogenase (LDH), creatine kinase, sodium , potassium, chloride, calcium, C- reactive protein.
Plasma Concentration of KN057
Maximum Plasma Concentration (Cmax) of KN057
Time to Reach Maximum Plasma Concentration (Tmax) of KN057
Maximum observed KN057 concentration at steady-state
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