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

Recruiting Phase 1 Phase 2 Interventional Study
End-Stage Renal Disease Requiring Haemodialysis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Prevention
Participants needed
12 (estimated)
Sponsor
Suzhou Alphamab Co., Ltd. · Industry
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About This Trial
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 thr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female subjects aged between 18 and 80 years (inclusive); 2. 1 8 kg /m \^2 \<BMI \<2 8 kg /m\^2 ; 3. Diagnosis of ESRD and be receiving regular, stable hemodialysis treatment within the three months prior to screening: dialysis is performed through a functional, non-i…
Contacts

Yanrong Dong, Master

+86 18914005458

yanrongdong@alphamab.com

CONTACT