A Phase Ib Clinical Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of SHR-2004 Injection in Patients With Atrial Fibrillation

This study is an open-label Phase Ib clinical study with the primary objective of evaluating the safety and tolerability of multiple subcutaneous injections of SHR-2004 injection in patients with atrial fibrillation, and the secondary objective is to evaluate its pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity characteristics.

Start Date01 Mar 2024

Sponsor / Collaborator

Beijing Suncadia Pharmaceuticals Co., Ltd

CTR20240133 / RecruitingPhase 2

评价使用SHR-2004注射液在卵巢癌手术患者中预防术后静脉血栓栓塞症的疗效与安全性的多中心、随机、开放标签、阳性对照II期临床研究

[Translation] A multicenter, randomized, open-label, positive-controlled phase II clinical study to evaluate the efficacy and safety of SHR-2004 injection in preventing postoperative venous thromboembolism in patients undergoing ovarian cancer surgery

评价使用SHR-2004注射液在卵巢癌手术患者中预防术后静脉血栓栓塞症（VTE）的疗效与安全性。

[Translation]

To evaluate the efficacy and safety of SHR-2004 injection in preventing postoperative venous thromboembolism (VTE) in patients undergoing ovarian cancer surgery.

Start Date16 Feb 2024

Sponsor / Collaborator

Beijing Suncadia Pharmaceuticals Co., Ltd

NCT06220123 / Not yet recruitingPhase 2

A Multicenter, Randomized, Open-label, Active-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery

This study is designed to evaluate the efficacy and safety of SHR-2004 injection in preventing postoperative venous thromboembolism in patients undergoing ovarian cancer surgery.

Start Date31 Jan 2024

Sponsor / Collaborator

Beijing Suncadia Pharmaceuticals Co., Ltd

100 Clinical Results associated with SHR-2004

100 Translational Medicine associated with SHR-2004

100 Patents (Medical) associated with SHR-2004

Literatures (Medical) associated with SHR-2004

02 Oct 2024·Expert Opinion on Investigational Drugs

The first-in-human study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the factor XI monoclonal antibody SHR-2004 in healthy subjects

Article

Author: Wang, Lei ; Shen, Kai ; Yang, Yuanxun ; Deng, Chanjuan ; Shen, Chenxi ; Huang, Lei ; Li, Juan ; Ma, Tingting ; Wang, Yuqi ; Cao, Bei ; Dong, Yanli ; Weng, Zuyi

BACKGROUNDInhibiting the coagulation factor XI (FXI) is a novel strategy for prevention and treatment of thromboembolism without affecting extrinsic coagulation pathways. SHR-2004 is a humanized monoclonal antibody that selectively binds to FXI and factor XIa (FXIa).RESEARCH DESIGN & METHODSThis randomized, double-blind, dose-escalation, placebo-controlled study evaluated SHR-2004 administered either intravenously (i.v.; Part A) or subcutaneously (s.c.; Part B). In Part A, 24 subjects received a single i.v. dose of SHR-2004 (0.1, 0.3, or 1.0 mg/kg) or placebo. In Part B, 40 subjects received a single s.c. dose of SHR-2004 (0.5, 1.0, 3.0, or 4.5 mg/kg) or placebo.RESULTSSHR-2004 was well tolerated. Plasma exposure to SHR-2004 increased in a dose-dependent manner. The geometric mean half-time ranged from 11.6 to 13.0 days. FXI activity decreased, and the activated partial thromboplastin time (APTT) was prolonged after i.v. and s.c. administration in a dose- and time-dependent manner. FXI activity was nearly completely abolished immediately after administering the highest i.v. dose, with the average APTT prolonged to nearly three times of baseline.CONCLUSIONSHR-2004 is a promising candidate for further development as an anticoagulant drug that exerts effective anticoagulation with minimal risk of bleeding.CLINICAL TRIAL REGISTRATIONwww.clinicaltrials.gov identifier is NCT05369767.

100 Deals associated with SHR-2004

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ovarian Cancer	Phase 2	-	Beijing Suncadia Pharmaceuticals Co., Ltd	31 Jan 2024
Venous Thromboembolism	Phase 2	CN	Beijing Suncadia Pharmaceuticals Co., Ltd	12 Apr 2023
Atrial Fibrillation	Phase 1	-	Beijing Suncadia Pharmaceuticals Co., Ltd	01 Mar 2024
Stroke	Phase 1	CN	Beijing Suncadia Pharmaceuticals Co., Ltd	21 Feb 2024
Systemic embolism	Phase 1	CN	Beijing Suncadia Pharmaceuticals Co., Ltd	21 Feb 2024
Arterial thrombosis	Phase 1	CN	Beijing Suncadia Pharmaceuticals Co., Ltd	24 May 2022
Venous Thrombosis	Phase 1	CN	Beijing Suncadia Pharmaceuticals Co., Ltd	24 May 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05369767 (ASH2023)	Phase 1	-	50	SHR-2004	(jtrvaefhyp) = irlvwvougw saahygrfen (ltlxsubxon ) View more	-	11 Dec 2023

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