Delving into the Latest Updates on STC3141 with Synapse

主要目的：评估持续静脉输注不同剂量STC314注射液在脓毒症患者中的疗效。次要目的：评估持续静脉输注不同剂量STC314注射液在脓毒症患者中的安全性。评估持续静脉输注不同剂量STC314注射液在脓毒症患者中的药代动力学特征。探索性目的：探索静脉输注不同剂量STC314注射液对脓毒症患者体内炎症状态的影响。

[Translation]

Primary purpose: To evaluate the efficacy of continuous intravenous infusion of different doses of STC314 injection in patients with sepsis. Secondary purpose: To evaluate the safety of continuous intravenous infusion of different doses of STC314 injection in patients with sepsis. To evaluate the pharmacokinetic characteristics of continuous intravenous infusion of different doses of STC314 injection in patients with sepsis. Exploratory purpose: To explore the effect of intravenous infusion of different doses of STC314 injection on the inflammatory state in patients with sepsis.

Start Date20 Nov 2023

Sponsor / Collaborator

Grand Pharmaceutical (China) Co., Ltd.

NCT06548854

/ Active, not recruitingPhase 2

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Dose Exploration Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Characteristics of STC314 Injection Administered Intravenously in Sepsis Patients

One study evaluated the efficacy and safety of intravenous STC314 injection in patients with sepsis Sex and pharmacokinetic profiles of a multicenter, randomized, double-blind, placebo-controlled II Phase I dose exploration clinical trial

Start Date20 Nov 2023

Sponsor / Collaborator

Grand Medical Pty Ltd.

CTR20211596

/ CompletedPhase 1

一项评估连续静脉输注STC314注射液在急性呼吸窘迫综合征中国患者中的安全性与耐受性及药代动力学的随机、双盲、安慰剂对照的Ib期临床研究

[Translation] A randomized, double-blind, placebo-controlled Phase Ib clinical study to evaluate the safety, tolerability and pharmacokinetics of continuous intravenous infusion of STC314 injection in Chinese patients with acute respiratory distress syndrome

主要目的：评估急性呼吸窘迫综合征患者持续72小时静脉输注STC314注射液的安全性与耐受性；评估急性呼吸窘迫综合征患者持续72小时静脉输注STC314注射液的药代动力学特征。次要目的：初步评估急性呼吸窘迫综合征患者持续72小时静脉输注STC314注射液疗效。探索性目的：探索静脉输注STC314注射液前后血液循环中组蛋白/NETs以及炎症因子相关指标的水平变化。

[Translation]

Primary purpose: To evaluate the safety and tolerability of 72-hour intravenous infusion of STC314 injection in patients with acute respiratory distress syndrome; to evaluate the pharmacokinetic characteristics of 72-hour intravenous infusion of STC314 injection in patients with acute respiratory distress syndrome. Secondary purpose: To preliminarily evaluate the efficacy of 72-hour intravenous infusion of STC314 injection in patients with acute respiratory distress syndrome. Exploratory purpose: To explore the changes in the levels of histone/NETs and inflammatory factor-related indicators in the blood circulation before and after intravenous infusion of STC314 injection.

Start Date20 Oct 2021

Sponsor / Collaborator

Grand Medical Pty Ltd.

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100 Clinical Results associated with STC3141

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100 Translational Medicine associated with STC3141

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100 Patents (Medical) associated with STC3141

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Literatures (Medical) associated with STC3141

01 Oct 2024·Pharmacology Research & Perspectives

A dose‐adjusted, open‐label, pilot study of the safety, tolerability, and pharmacokinetics of STC3141 in critically ill patients with sepsis

Article

Author: Udy, Andrew ; Bellomo, Rinaldo ; Plummer, Mark ; McNamara, Robert ; Layios, Nathalie ; Attou, Rachid ; Tanudji, Marcel ; Wibrow, Bradley ; Litton, Edward ; Peetermans, Marijke ; Zhong, Zhang ; Shi, Linda ; Van Lancker, Ruth ; Deane, Adam ; Ning, Li ; Patava, John ; Su, Fuhong

AbstractIncreased circulating histones correlate with sepsis severity and are a potential therapeutic target. Pre‐clinical studies showed benefit with a histone‐neutralizing polyanion molecule (STC3141). We aimed to investigate the safety, tolerability, and pharmacokinetics of STC3141 in critically ill patients with sepsis. We studied 26 patients with sepsis divided into four cohorts of one, five, ten, and ten subjects, respectively. We conducted a dose‐adjusted, open‐label study to determine the safety, tolerability, and pharmacokinetics of STC3141 administered as an IV infusion for up to 72 h, with rate adjusted to estimated creatinine clearance. Four steady‐state concentrations were targeted. Twenty of the 26 subjects (77%) in the study experienced at least one adverse event (AE). The most frequently reported study drug‐related AE was a mildly prolonged aPTT (four events). Only one AE (pulmonary hemorrhage) led to discontinuation of the drug. After excluding patients receiving renal replacement therapy (RRT) patients, clearance ranged from 3.3 to 4.2 L/h across cohorts and was essentially completely renal in nature. Half‐life values ranged from 5 to 7 h. The mean (±SD) terminal half‐life for non‐RRT subjects and for whom it was possible to calculate was approximately 9 (±4.77) h but increased to 19 (±7.94) h for subjects on RRT. Overall, 18 (69.2%) patients completed the study to day eight in the ICU, and 22 (84.6%) survived to 28 days. STC3141 administration appeared to have an acceptable degree of safety and tolerability and expected pharmacokinetics. Cautious, larger randomized efficacy trials in sepsis appear justified.

01 Jan 2023·Frontiers in pharmacology

STC3141 improves acute lung injury through neutralizing circulating histone in rat with experimentally-induced acute respiratory distress syndrome.

Article

Author: Wang, Yong ; Wang, Li ; Yao, Shanglong ; Wang, Fuquan ; Ge, Yangyang ; Chen, Jiayi ; Zheng, Yuduo ; Wang, Chenchen ; Lin, Yun ; Shi, Lin ; Wang, Yu ; Yao, Chenye ; Luo, Junjie

Background: Acute respiratory distress syndrome (ARDS) remains a challenge because of its high morbidity and mortality. Circulation histones levels in ARDS patients were correlated to disease severity and mortality. This study examined the impact of histone neutralization in a rat model of acute lung injury (ALI) induced by a lipopolysaccharide (LPS) double-hit. Methods: Sixty-eight male Sprague-Dawley rats were randomized to sham (N = 8, received saline only) or LPS (N = 60). The LPS double-hit consisted of a 0.8 mg/kg intraperitoneal injection followed after 16 h by 5 mg/kg intra-tracheal nebulized LPS. The LPS group was then randomized into five groups: LPS only; LPS +5, 25, or 100 mg/kg intravenous STC3141 every 8 h (LPS + L, LPS + M, LPS + H, respectively); or LPS + intraperitoneal dexamethasone 2.5 mg/kg every 24 h for 56 h (LPS + D). The animals were observed for 72 h. Results: LPS animals developed ALI as suggested by lower oxygenation, lung edema formation, and histological changes compared to the sham animals. Compared to the LPS group, LPS + H and +D groups had significantly lower circulating histone levels and lung wet-to-dry ratio, and the LPS + D group also had lower BALF histone concentrations; the blood neutrophils and platelets counts in LPS + D group did not change, meanwhile, the LPS + L, +M and +H groups had significantly lower neutrophil counts and higher platelet counts in the blood; the total number of BALF WBC, platelet counts, MPO and H3 were significantly lower in the LPS + L, +M, +H and +D groups than in the LPS only group; and the degree of inflammation was significantly less in the LPS + L, +M, +H and +D groups, moreover, inflammation in the LPS + L, +M and +H animals showed a dose-dependent response; finally, the LPS + L, +M, +H and +D groups had improved oxygenation compared to the LPS group, and there were no statistical differences in PCO2 or pH among groups. All animals survived. Conclusion: Neutralization of histone using STC3141, especially at high dose, had similar therapeutic effects to dexamethasone in this LPS double-hit rat ALI model, with significantly decreased circulating histone concentration, improved acute lung injury and oxygenation.

01 Dec 2020·Journal of law and medicine

Clinical Research without Consent: Challenges for COVID-19 Research.

Article

Author: Freckelton, Ian

The imperatives generated by the need for research into efficacious forms of treatment for COVID-19 have shone a fresh light upon the criteria for inclusion in clinical trials of persons unable to provide informed consent by reason of a number of factors including the seriousness of their illness symptomatology. This column identifies diversity in European, United States and Australian legislative and other guidance on the ethical issues that arise in respect of clinical research to which participants are not able to consent. It reviews the decision-making by the New South Wales Civil and Administrative Tribunal in a 2020 case in which permission was sought to conduct a clinical trial into a drug, STC 3141, designed by researchers as a potential treatment for patients with Adult Respiratory Distress Syndrome arising from COVID-19. It outlines the reasoning of the Tribunal in the context of debates about the balance to be struck between clinically useful medication trials and the need to avoid exploitation of vulnerable persons not able to provide their own consent, be that by virtue of disabilities such as acuteness of illness or dementia symptomatology. It contends that the decision illustrates the potential for research to be undertaken safely and ethically, utilising subjects in an intensive care unit who are unable to provide consent.

100 Deals associated with STC3141

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sepsis	Phase 2	China	Grand Medical Pty Ltd.	20 Nov 2023
Sepsis	Phase 2	China	Grand Pharmaceutical (China) Co., Ltd.	20 Nov 2023
Respiratory Distress Syndrome, Acute	Phase 2	China	Grand Pharmaceutical (China) Co., Ltd.	20 Oct 2021
Respiratory Distress Syndrome, Acute	Phase 2	China	Grand Medical Pty Ltd.	20 Oct 2021
Respiratory Distress Syndrome, Acute	Phase 2	China	Sypharma Pty Ltd.	20 Oct 2021
Respiratory Distress Syndrome, Adult	Phase 2	China	Grand Medical Pty Ltd.	28 Jul 2021
Respiratory Distress Syndrome, Adult	Phase 2	China	Grand Pharmaceutical (China) Co., Ltd.	28 Jul 2021
COVID-19	Phase 2	Belgium	Grand Medical Pty Ltd.	20 May 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05000671 (NEWS) Manual	Phase 1	Respiratory Distress Syndrome, Adult	16	STC3141	(pbjuvtekhk) = 总体安全性特征未提示任何潜在严重安全性问题或非预期结果，安全性及耐受性良好 juqqotuper (osbbopkfpz )	Positive	31 Oct 2022
NCT04880694 (NEWS) Manual	Phase 2	COVID-19	25	standard treatment+STC3141	xuvzmllemg(rcpljlqjmu) = 達到了臨床方案預設的主要終點，未發生藥物相關的嚴重不良反應，患者耐受性良好 yvvdwjvdet (rwpzzxhdiz )	Positive	27 Jul 2022
NCT04880694 (NEWS) Manual	Phase 2	COVID-19	25	standard treatment		Positive	27 Jul 2022