A Phase 2 interventional study of KN057 doseⅠ and KN057 dose Ⅱ in Hemophilia, sponsored by Suzhou Alphamab Co., Ltd.. Completed at 2 sites in China. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Suzhou Alphamab Co., Ltd. · Phase 2, Interventional, and Prevention
This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of multiple subcutaneous doses of KN057 in subjects with hemophilia A or B, with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). 24 adult participants 18 to 70 years of age with moderately severe to severe hemophilia A or hemophilia B (defined as FVIII or FIX activity ≤2%, respectively) with or without inhibitors (including 18 HA/HB patients without inhibitors and 6 HA/HB patients with inhibitors) are expected to be enrolled in this study during which they will receive prophylaxis treatment (defined as treatment by SC injection once weekly of KN057).
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 24 is below the median of 28 across 512 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Suzhou Alphamab Co., Ltd. is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants who are enrolled into the Non-Inhibitor Cohort must meet the following criteria:
①negtive results of of inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in screening period.
②with ≥6 acute bleeding episodes (spontaneous or traumatic, not including episodes of bleeding during surgery) that required treatment within 6 months before screening and willing to continue to receive on-demand treatment during the study.
③using coagulation factor replacement therapy for more than 50 exposure days before screening.
Participants who are enrolled into the Inhibitor Cohort must meet the following criteria:
①positive results of inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in screening period.
②with ≥6 acute bleeding episodes (spontaneous or traumatic, not including episodes of bleeding during surgery) that required treatment within 6 months before screening and willing to continue to receive on-demand treatment during the study.
Exclusion Criteria:
Injection, once a week
Biological: KN057 doseⅠ
Injection, once a week
Biological: KN057 dose Ⅱ
Injection, once a week
Biological: KN057 dose Ⅱ
Injection, once a week
Biological: KN057 dose Ⅲ
KN057 subcutaneous (SC) injection
KN057 SC injection
KN057 SC injection
Frequency and severity of treatment emergent adverse events(TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. A serious adverse event (SAE) is any untoward medical occurrence at any dose that resulted in death; life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment.
Time frame: Day 1 up to Day 85
Withdrawals due to TEAEs
An AE is any untoward medical occurrence in a clinical investigation participant administered a product and the event does not need to have a causal relationship with the treatment. TEAEs are AEs occurred following the start of treatment or AEs increasing in severity during treatment.
Time frame: Day 1 up to Day 85
Number of Participants With Abnormal Laboratory Findings-Hematology
White blood cells, red blood cells; the count of lymphocyte, neutrophils, monocytes, eosinophils, basophils; the percentage of lymphocyte, neutrophils, monocytes, eosinophils, basophils; hemoglobin, red blood cell pressure, platelet count
Time frame: Day 1 up to Day 85
Number of Participants With Abnormal Laboratory Findings-Urinalysis
blood, urobilirubin, urobiliogen, ketone body, protein, nitrite, red blood cell (qualitative and/or quantitative), white blood cell (qualitative and/or quantitative), pH, urinary glucose.
Time frame: Day 1 up to Day 85
Number of Participants With Abnormal Laboratory Findings-Blood biochemistry
Total bilirubin and indirect bilirubin, direct bilirubin, alanine aminotransferase, aspertate aminotransferase, GGTP (gamma glutamyl transpeptidase), alkaline phosphatase, total protein, albumin, globulin, albumin-globulin ratio, urea, creatinine, uric acid, glucose, total cholesterol, triglyceride, low density lipoprotein cholesterol (ldl-c), high-density lipoprotein cholesterol (hdl-c), lactate dehydrogenase, creatine kinase, chlorine, calcium, sodium, potassium, C reactive protein
Time frame: Day 1 up to Day 85
Number of Participants With Abnormal Laboratory Findings-Coagulation tests
Prothrombin time (PT), International Standardized ratio (INR), Activated partial thrombin time (APTT), thrombin time (TT), fibrinogen (FBG/FIB), D-dimer (D-DI), fibrinogen degradation product (FDP), antithrombin - ⅲ (AT- ⅲ)
Time frame: Day 1 up to Day 85
Number of Participants With Clinically Significant Changes in Vital Signs Data
Vital signs：blood pressure (systolic blood pressure, diastolic blood pressure), respiration, temperature, pulse；
Time frame: Day 1 up to Day 85
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
ECG: HR; RR; PR; QRS; QT; QTc
Time frame: Day 1 up to Day 85
Number of Participants With Clinically Significant Changes in Physical Examination Findings
Physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Clinical significance was judged by the investigator.
Time frame: Day 1 up to Day 85
Number of Participants With Injection Site Reactions
Injection site reactions may include, but are not limited to: erythema, sclerosis, ecchymosis, pain, and itching.
Time frame: Day 1 up to Day 85
Maximum Plasma Concentration (Cmax) of KN057
Time frame: Day 1 up to Day 8
Time to Reach Maximum Plasma Concentration (Tmax) of KN057
Time frame: Day 1 up to Day 8
Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of KN057
Time frame: Day 1 up to Day 8
Cmax,ss: Maximum observed KN057 concentration at steady-state
Time frame: Day 36 up to Day 43
Time to Reach Maximum Plasma Concentration at steady-state (Tmax,ss) of KN057
Time frame: Day 36 up to Day 43
Area Under the Serum Concentration-time Curve Over the Dosing Interval Tau (AUCtau) of KN057
Time frame: Day 36 up to Day 43
Apparent Clearance (CL/F) of KN057
Time frame: Day 36 up to Day 43
Lowest Concentration Observed During the Dosing Interval (Cmin) of KN057
Time frame: Day 36 up to Day 43
Pharmacodynamics index: Changes of TFPI from baseline;
Tissue factor (TF) pathway inhibitor (TFPI) is an anticoagulant protein that inhibits early phases of the procoagulant response. TFPI: Total TFPI, Free TFPI
Time frame: Day 1 up to Day 169
Pharmacodynamics index: Changes of Prothrombin fragment 1+2 (PF1+2) from baseline;
Prothrombin fragment 1+2 (F1+2) is the amino terminus fragment of the prothrombin molecule.
Time frame: Day 1 up to Day 169
Pharmacodynamics index: Thrombin Generation (TGA);
Lag Time; Peak Thrombin; Endogenous Thrombin Potential;
Time frame: Day 1 up to Day 169
Number of Participants Who Tested Positive for Anti-KN057 Antibody (ADA)
Human plasma ADA samples were analyzed for the detection of anti KN057 antibodies.
Time frame: Day 1 up to Day 169
Number of Participants Who Tested Positive for Neutralizing Antibody (NAb)
Human plasma NAb samples were analyzed for the presence or absence of NAb to KN057.
Time frame: Day 1 up to Day 169
Annualized Bleeding Rate
ABR = number of bleeds requiring treatments/ (days on treatment period / 365.25)
Time frame: Day 1 up to Day 169
Plan to share: Undecided
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Suzhou Alphamab Co., Ltd.