An Open, Randomized, Active-comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of Different Doses of KN060 for the Prevention of Venous Thromboembolism in Patients Undergoing Unilateral Total Knee Arthroplasty.

This study was to compare the study drug KN060 to enoxaparin, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA).

Start Date20 Dec 2023

Sponsor / Collaborator

Suzhou Alphamab Co., Ltd.

CTR20233320

/ Active, not recruitingPhase 2

在单侧全膝关节置换术患者中，评价不同剂量KN060预防静脉血栓栓塞的有效性及安全性的一项随机、开放、阳性对照的多中心研究

[Translation] A randomized, open-label, positive-controlled, multicenter study to evaluate the efficacy and safety of different doses of KN060 in preventing venous thromboembolism in patients undergoing unilateral total knee replacement

主要目的：在行择期、首次、单侧全膝关节置换术(TKA)的患者中，评估不同剂量KN060对比依诺肝素钠注射液（依诺肝素）预防静脉血栓栓塞（VTE）的有效性。次要目的：在行择期、首次、单侧TKA的患者中，评估：不同剂量KN060对比依诺肝素的安全性；单次静脉滴注KN060的药代动力学及药效学特点；KN060预防TKA术后VTE的剂量-效应关系。

[Translation]

Primary objective: To evaluate the effectiveness of different doses of KN060 compared with enoxaparin sodium injection (enoxaparin) in preventing venous thromboembolism (VTE) in patients undergoing elective, first, unilateral total knee arthroplasty (TKA). Secondary objective: To evaluate the safety of different doses of KN060 compared with enoxaparin in patients undergoing elective, first, unilateral TKA; the pharmacokinetic and pharmacodynamic characteristics of a single intravenous infusion of KN060; and the dose-effect relationship of KN060 in preventing VTE after TKA.

Start Date19 Dec 2023

Sponsor / Collaborator

Suzhou Alphamab Co., Ltd.

CTR20222339

/ CompletedPhase 1

评估KN060注射液在中国健康受试者中安全性、耐受性、药代动力学和药效学的I期临床研究

[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of KN060 injection in healthy Chinese subjects

评价在中国健康受试者中，KN060单次静脉滴注的安全性和耐受性。

[Translation]

To evaluate the safety and tolerability of a single intravenous infusion of KN060 in healthy Chinese subjects.

Start Date16 Sep 2022

Sponsor / Collaborator

Suzhou Alphamab Co., Ltd.

100 Clinical Results associated with Lofacimig

100 Translational Medicine associated with Lofacimig

100 Patents (Medical) associated with Lofacimig

100 Deals associated with Lofacimig

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Venous Thromboembolism	Phase 2	China	Suzhou Alphamab Co., Ltd.	19 Dec 2023
Essential Hypertension	IND Approval	China	Suzhou Alphamab Co., Ltd.	03 Mar 2025

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