RecruitingPhase 1Phase 2NCT07201467

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


Sponsor

Suzhou Alphamab Co., Ltd.

Enrollment

12 participants

Start Date

Aug 22, 2025

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called KN060 for people with end-stage renal disease requiring haemodialysis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKN060

pharmacokinetic and pharmacodynamic characteristics of KN060 in ESRD on Hemodialysis


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT07201467


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