To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients
Phase 1b Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in Patients With End Stage Renal Disease Receiving Regular Hemodialysis
Suzhou Alphamab Co., Ltd.
12 participants
Aug 22, 2025
INTERVENTIONAL
Conditions
Summary
The primary objective of this study is to assess the safety and tolerability of KN060 in patients with end-stage renal disease on regular hemodialysis. The secondary objectives to evaluate the pharmacokinetic and pharmacodynamic properties of multiple doses of KN060; to evaluate the immunogenicity of KN060; and to explore the efficacy of KN060 in preventing dialyzer and extracorporeal circuit thrombosis, arteriovenous fistula thrombosis in patients with end-stage renal disease undergoing regular hemodialysis. The main questions it aims to answer are: * Whether KN060 is safe for ESRD dialysis patients * Pharmacokinetic characteristics of KN060 in ESRD dialysis patients * Whether KN060 can effectively prevent dialyzer and extracorporeal circuit thrombosis Researchers will evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics profile, dialyzer and extracorporeal circuit thrombosis, arteriovenous fistula thrombosis of KN060 in ESRD dialysis patients Subjects will : * Eligible subjects will receive KN060 2.5 mg/kg every two weeks for a total of 6 doses. * Assessed for the number, incidence, and severity of AEs, dialyzer thrombus, extracorporeal circuit thrombus, arteriovenous fistula thrombus, and time to hemostasis at the arteriovenous fistula puncture site.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
pharmacokinetic and pharmacodynamic characteristics of KN060 in ESRD on Hemodialysis
Locations(1)
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NCT07201467