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

NCT07201467 | Recruiting Phase 1

• 1 other identifier: KN060-C-102
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End-Stage Renal Disease Requiring Haemodialysis

Outcome Measures

Primary Outcomes (1)

• Safety Results

  Number, frequency, incidence and severity of treatment-emergent adverse events (TEAEs), drug-related adverse events (TRAEs), adverse events of special interest (AESIs), serious adverse events (SAEs), etc.

  up to 18 weeks

Secondary Outcomes (6)

• Pharmacokinetics characteristics

  up to 18 weeks

• Pharmacodynamic characteristics

  up to 18 weeks

• Immunogenicity Results

  up to 18 weeks

• Bleeding Events

  up to 18 weeks

• Thrombosis events

  up to 18 weeks

Study Arms (1)

KN060

EXPERIMENTAL

KN060 diluted in normal saline and administered via proximal (arterial) dialysis line

Drug: KN060

Interventions

KN060 DRUG

pharmacokinetic and pharmacodynamic characteristics of KN060 in ESRD on Hemodialysis

KN060

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged between 18 and 80 years (inclusive);
• kg /m \^2 \<BMI \<2 8 kg /m\^2 ;
• Diagnosis of ESRD and be receiving regular, stable hemodialysis treatment within the three months prior to screening: dialysis is performed through a functional, non-infected graft arteriovenous fistula / autologous arteriovenous fistula ( AVG/AVF ) ; dialysis is performed three times per week, with at least 3.5 hours per session ( at least 75% of dialysis sessions within the four weeks prior to randomization meet the this criteria) ;
• The clinical status of the underlying ESRD is stable (assessed by the investigator) ;
• Kt/V ≥ 1.2 within 3 months before screening ;
• Male subjects: From the time they sign the informed consent form until 3 months after the last dose of KN060 , they agree to take effective contraceptive measures and avoid sperm donation ( effective contraceptive methods include: consistent scientific use of condoms , vasectomy , or partners who have undergone tubal ligation or hysterectomy, or have an intrauterine device implanted, etc. );
• Women who are infertile and have no plans to have children (surgical infertility: such as after hysterectomy, bilateral salpingectomy , bilateral oophorectomy; or natural menopause: amenorrhea for ≥ 12 months and serum follicle-stimulating hormone (FSH) at menopausal levels ).

You may not qualify if:

• A history of malignant tumor;
• History of mechanical/artificial heart valve replacement surgery;
• History of major medical events within 3 months before screening , such as acute coronary syndrome, stroke , major organ bleeding, acute heart failure, systemic thromboembolic events , major surgery, etc. , or history of AVF/AVG functional loss;
• Using anticoagulant/antiplatelet drugs due to disease treatment , such as warfarin , dabigatran, rivaroxaban , clopidogrel , or aspirin \>100 mg/day (investigators are allowed to use heparin / low molecular weight heparin during dialysis, depending on the situation );
• There is a high risk of bleeding, or abnormal bleeding-related indicators:
• ） Bleeding requiring hospitalization or clinically significant active bleeding within 3 months before screening ; prolonged arteriovenous fistula compression time within the past month; 2） Platelet count (PLT) \<100 × 10\^ 9 /L ( PLT between 75-100 × 10\^9 /L , determined by the investigator after comprehensive evaluation), hemoglobin ( Hb ) \< 90 g/L ; 3） Normalized ratio INR\>1.4 , activated partial thromboplastin time ( APTT ) \> 1.2 times ULN ; 4） Liver disease-related laboratory abnormalities: increased bleeding risk due to coagulation disorders , alanine aminotransferase (ALT) \> 3 times ULN , aspartate aminotransferase ( AST) \> 3 times ULN , total bilirubin (TB) \> 2 times ULN and direct bilirubin proportion \> 20%; 5） Poor blood pressure control in the past month before screening (judged by the investigator, such as repeated diastolic blood pressure ≥100 mmHg and/or systolic blood pressure ≥180 mmHg ) ; 6） Underwent brain, spinal or eye surgery (excluding cataract surgery) within three months before screening; 7） The patient has a bleeding disorder, a medical history that may increase the risk of bleeding, any condition that the investigator believes increases the risk of bleeding, or a history of severe bleeding disorders, such as massive gastrointestinal bleeding or cerebral hemorrhage ; 6. Supine blood pressure is \< 90/50 mmHg , or \> 170/100 mmHg (one retest is allowed) during screening; 7. Electrocardiogram during screening: heart rate \< 45 beats / min or \> 110 beats / min, QTcF \> 500 ms, any significant arrhythmia or conduction abnormality ( e.g. Second degree or above atrioventricular block, preexcitation syndrome (except those who have undergone radical radiofrequency ablation) , non-sustained or sustained ventricular tachycardia (one retest is allowed); 8. History (\<1 year) of drug or alcohol abuse or dependence before screening; 9. Have a history of allergy, or be allergic to the experimental drug/similar drugs or excipients; 10. Human immunodeficiency virus (HIV ) infection, syphilis infection, active HBV infection (HBV -DNA\>ULN ), active HCV infection (HCV - RNA \> ULN ) ; 11. Participated in another clinical trial and received trial drugs within 3 months before screening (signing ICF); 12. Plan to receive a kidney transplant during the trial or within 3 months after completing this trial; 13. Xanthine, coffee (small amounts of caffeine from normal food sources, such as chocolate, are permitted), or alcohol cannot be prohibited during the study; 14. Any concomitant disease or condition that the investigator believes may interfere with the study drug, affect study data, or pose a risk to patient safety.

Sponsors & Collaborators

• Suzhou Alphamab Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

• Li Zuo, Doctor

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Yuqing Chen

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanrong Dong, Master

CONTACT

+86 18914005458; yanrongdong@alphamab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 1, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)