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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
KN057 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.
Time frame: Week 0 up to Week 26
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.
Time frame: Week 0 up to Week 26
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)
Time frame: Week 0 up to Week 26
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.
Time frame: Week 0 up to Week 26
Number of participants with clinically significant changes in 12-lead electrocardiograms
Time frame: Week 0 up to Week 26
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Number of participants with clinically significant changes in vital signs
Heart Rate, Respirations, Temperature, Blood Pressure
Time frame: Week 0 up to Week 26
Number of participants with clinically significant changes in physical examination Findings
Time frame: Week 0 up to Week 26
Incidence and severity of injection site reaction
Time frame: Week 0 up to Week 26
Plasma Concentration of KN057
Time frame: Week 0 up to Week 26
Maximum Plasma Concentration (Cmax) of KN057
Time frame: Week 0 up to Week 26
Time to Reach Maximum Plasma Concentration (Tmax) of KN057
Time frame: Week 0 up to Week 26
Maximum observed KN057 concentration at steady-state
Time frame: Week 0 up to Week 26
Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of KN057
Time frame: Week 0 up to Week 26
Apparent Clearance (CL/F) of KN057
Time frame: Week 0 up to Week 26
Changes of Free Tissue factor pathway inhibitor (TFPI) from baseline
Tissue factor pathway inhibitor (TFPI) is an anticoagulant protein that inhibits early phases of the procoagulant response.
Time frame: Week 0 up to Week 26
Changes of Total TFPI from baseline
TFPI: Tissue factor pathway inhibitor
Time frame: Week 0 up to Week 26
Changes of Prothrombin fragment 1+2 (PF1+2) from baseline
Time frame: Week 0 up to Week 26
The number and proportion of participants who produce anti-KN057 antibody
Time frame: Week 0 up to Week 26
The number and proportion of participants who produce anti-KN057 neutralizing antibodies
Time frame: Week 0 up to Week 26
Annualized Bleeding Rate (ABR)
ABR=number of bleeding episodes reported in visit days÷visit days×365.25
Time frame: Week 0 up to Week 20