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RECRUITING
NCT07201467
PHASE1/PHASE2

To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients

Sponsor: Suzhou Alphamab Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: Phase 1b Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in Patients With End Stage Renal Disease Receiving Regular Hemodialysis

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-08-22

Completion Date

2027-12-15

Last Updated

2025-10-01

Healthy Volunteers

No

Interventions

DRUG

KN060

pharmacokinetic and pharmacodynamic characteristics of KN060 in ESRD on Hemodialysis

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China