[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetics of norcantharidin lipid microsphere injection in patients with solid tumors

主要目的：观察去甲斑蝥素脂质微球注射液在人体中的安全性，确定其剂量限制性毒性（DLT）、最大耐受剂量（MTD），为后期临床研究推荐剂量。次要目的：评价去甲斑蝥素脂质微球注射液在人体的药代动力学特征，并与已上市的注射用去甲斑蝥酸钠进行对比，探讨脂质微球剂型所引起的药代及初步安全性变化。

[Translation]

The primary objective is to observe the safety of norcantharidin lipid microsphere injection in humans, determine its dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), and recommend the dose for later clinical studies. The secondary objective is to evaluate the pharmacokinetic characteristics of norcantharidin lipid microsphere injection in humans, and compare it with the marketed norcantharidin sodium for injection to explore the pharmacokinetic and preliminary safety changes caused by the lipid microsphere dosage form.

Start Date22 Sep 2020

Sponsor / Collaborator

Shenyang Pharmaceutical University

CTR20201906 / RecruitingPhase 1/2

一项评价淋巴示踪用盐酸米托蒽醌注射液用于胃癌患者淋巴示踪的单盲、单中心、安全性、耐受性、药代动力学特征及初步疗效的剂量递增和剂量扩展的I期/IIa 期临床试验研究

[Translation] A single-blind, single-center, dose-escalation and dose-expansion clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of mitoxantrone hydrochloride injection for lymphatic tracing in patients with gastric cancer.

本试验的目的是探索淋巴示踪用盐酸米托蒽醌注射液对胃癌患者淋巴示踪的有效性、安全性和耐受性并确定试验用药物最优使用剂量范围，同时探索淋巴示踪用盐酸米托蒽醌注射液对胃癌患者的药代动力学特征，为III 期临床试验的用药剂量及评价指标提供合理依据。

[Translation]

The purpose of this trial is to explore the efficacy, safety and tolerability of mitoxantrone hydrochloride injection for lymphatic tracing in patients with gastric cancer and determine the optimal dosage range of the trial drug. At the same time, it is to explore the pharmacokinetic characteristics of mitoxantrone hydrochloride injection for lymphatic tracing in patients with gastric cancer, and to provide a reasonable basis for the dosage and evaluation indicators of the Phase III clinical trial.

Start Date01 Sep 2020

Sponsor / Collaborator

Shenyang Xintager Pharmaceutical Technology Development Co., Ltd.

[+2]

CTR20200992 / CompletedPhase 1

盐酸小檗碱缓释胶囊在健康受试者中单次、多次给药及食物影响的安全性、耐受性及药代动力学的Ⅰ期临床研究

[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetics of berberine hydrochloride sustained-release capsules in healthy subjects after single and repeated administration and food effects

评价盐酸小檗碱缓释胶囊在健康受试者中单次、多次给药的安全性、耐受性，确定最大耐受剂量，剂量限制性毒性，确定Ⅱ期临床推荐剂量。观察空腹和进食状态下健康受试者单次口服盐酸小檗碱缓释胶囊药代动力学的差异。评价盐酸小檗碱缓释胶囊在健康受试者中单次、多次给药的药代动力学特征及临床应用的安全性。

[Translation]

To evaluate the safety and tolerability of berberine hydrochloride sustained-release capsules in healthy subjects after single and multiple administrations, determine the maximum tolerated dose, dose-limiting toxicity, and determine the recommended dose for Phase II clinical trials. To observe the differences in the pharmacokinetics of berberine hydrochloride sustained-release capsules in healthy subjects after a single oral administration between fasting and feeding. To evaluate the pharmacokinetic characteristics of berberine hydrochloride sustained-release capsules in healthy subjects after single and multiple administrations and the safety of clinical application.

Start Date27 May 2020

Sponsor / Collaborator

Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences

[+3]

100 Clinical Results associated with Shenyang Pharmaceutical University

0 Patents (Medical) associated with Shenyang Pharmaceutical University

21,590

Literatures (Medical) associated with Shenyang Pharmaceutical University

01 Jan 2025·Journal of Ethnopharmacology

Quercus dentata Thunb. leaves extract inhibits CaOx crystallization and ameliorates ethylene glycol-induced CaOx kidney stones via the OPN/CD44 and NLRP3 pathways

Article

Author: Xu, Hui-Yuan ; Liu, Xiao-Qiu ; Wang, Dong-mei ; Pan, Ying-ni ; Ren, Shu-meng ; Zhang, Chu-Hao ; Zhang, Chu-hao ; Wang, Dong-Mei ; Pan, Ying-Ni ; Zhang, Qing-zhu ; Feng, Chao-yan ; Feng, Chao-Yan ; Ren, Shu-Meng ; Liu, Xiao-qiu ; Xu, Hui-yuan ; Zhang, Qing-Zhu ; Ren, Kun

ETHNOPHARMACOLOGICAL RELEVANCEThe leaves of Quercus dentata Thunb. (QD), a member of the Fagaceae family and genus Quercus, with distributions in China, Japan, Korea, and other regions. As recorded in the Ben Cao Gang Mu (Compendium of Materia Medica) and other classical Chinese medical texts, QD has been traditionally employed in Traditional Chinese Medicine (TCM) for their hemostatic and diuretic effects and has been used to treat urinary stones (Lin Zheng). It is also the main ingredient of the Mishitong capsule (MST), a Chinese patent drug, used for kidney stones and ureteral stones. Nonetheless, the specific active ingredients and the mechanisms of QD in treating kidney stones remain to be elucidated, which is crucial for advancing the scientific understanding and clinical application of this traditional medicine.AIM OF STUDYThis study aimed to identify the active constituents of QD water extract (QDWE), explore its inhibitory effects on kidney stones through in vitro and in vivo studies, and elucidate the underlying mechanisms of the OPN/CD44 axis and the NLRP3 signaling pathway to provide a full understanding of its potential as a novel treatment approach against kidney stones.MATERIALS AND METHODSThe micromolecular components in the supernatant of QDWE (QDS) were analyzed by UPLC-Q-Exactive-Orbitrap-MS and the monosaccharide composition of the macromolecular polysaccharide components in the crude polysaccharide (QDP) was determined by pre-column derivatization in HPLC. The effects of QDWE, QDS and QDP on the shape, size, and structure of calcium oxalate (CaOx) crystals in vitro were explored by XRD, FTIR and SEM. The effects of QDWE, QDS and QDP on CaOx kidney stones in SD rats induced by ethylene glycol and VD₃ were compared in vivo. Furthermore, the underlying mechanisms of OPN/CD44 and NLRP3 pathways were investigated by Western blot analysis.RESULTSThere were 32 compounds identified in QDS. The monosaccharide composition ratio of QDP was Man: L-Rha: D-GlcA: D-GalA: D-Glc: D-Gal: L-Ara = 1.01: 22.52: 8.27: 38.61: 3.43: 17.80: 6.38, indicating a mixture of pectin-type acidic heteropolysaccharides. QDP had a more significant inhibitory effect on CaOx crystals in vitro than QDWE, which can inhibit the formation of CaOx monohydrate crystals (COM) and convert them into thermodynamically unstable CaOx dihydrate (COD) crystals. The high dose of QDWE exhibited significant in vivo efficacy (P < 0.05), including anti-calculus, diuretic effects, and kidney protection, marked by decreased calcification and stone formation, alongside improved kidney vitality. Furthermore, the protective effects of QDWE were demonstrated to be associated with the OPN/CD44 and NLRP3 pathways.CONCLUSIONThe studies identified and analyzed the active constituents of QDWE. Among these, QDP significantly inhibited CaOx crystal generation in vitro and could be a potential component for the treatment of urinary stones in QDWE. Moreover, the results indicated that QDWE had a remarkable therapeutic effect on CaOx stones by modulating the OPN/CD44 axis to affect stone formation and the NLRP3 signaling pathway to mediate inflammation, providing an experimental basis for the mechanism of anti-urinary stone and deep development of QD.

01 Jan 2025·Journal of Pharmaceutical and Biomedical Analysis

Repeated lyophilization: A neo-method for urine-based reference materials preparation

Article

Author: Chen, Hang ; Zhang, Wenping ; Zhi, Yujie ; Zheng, Qiongying ; Zhang, Zhen ; Lu, Jiayue ; Hu, Jing ; Liu, Yu ; Liu, Wei ; Dou, Quanlu ; Jin, Wenhui

In urine drug testing, a cut-off value is often imposed to determine whether the sample is negative or positive. A matrix containing a reference substance helps counteract the adverse effects of the urine matrix across different laboratories to improve the consistency of final results. However, as a biological matrix, urine is prone to corruption and other problems that make it difficult to use as a reference sample. In this study, morphine, nitrazepam, lorazepam, buprenorphine, zolpidem, midazolam, diazepam, and clozapine commonly used in clinical practice were selected as target analytes, and the preparation process was further optimized to repeated lyophilization, in order to obtain more effective, stable, and accurate urine matrix reference materials (mRMs). The appropriate urine density (1.010-1.017 kg/m³) for preparing lyophilized samples was investigated through density determination. Conducting repeated lyophilizations resulted in a denser powder with reduced susceptibility to collapse and improved the quality of lyophilized urine samples. Lyophilized urine mRMs could be stored at room temperature for one month or under refrigeration conditions (4 ℃) for six months.

01 Jan 2025·Journal of Colloid and Interface Science

Dual role of triglyceride structures facilitates anti-tumor drug delivery: Both as a self-assembling module and a responsive module

Article

Author: Shi, Xianbao ; Liu, Jinrui ; Li, Yaqi ; Sun, Bingjun ; Tian, Chutong ; He, Zhonggui ; Wang, Zixuan ; Zhong, Wenxin ; Zhao, Can ; Xu, Yalin ; Wang, Xiyan

Small molecule prodrugs self-assembled nano-delivery systems with tumor responsive linkages are emerging as an effective platform. However, the heterogeneity of tumor microenvironment may limit the anti-tumor effect of prodrug nanomedicines with a single response module. Here, we chose disulfide bond as the response module and branched chain alcohol as the self-assembly modification module to construct a single-responsive prodrug. We also constructed a double-responsive paclitaxel prodrug combining triglyceride and disulfide bond, taking into account of the highly expressed lipase and glutathione levels in tumor cells. The results showed that the anti-tumor effect of single-responsive branched chain alcohol modified prodrug nanoparticles was inferior to triglyceride prodrug nanoparticles with dual response modules. The triglyceride structure can not only serve as a self-assembly modification module, but also serve as a response module for intelligent drug release in tumor. Such dual roles will facilitate the efficient delivery of small molecule self-assembled prodrugs to tumor sites.

100 Deals associated with Shenyang Pharmaceutical University

100 Translational Medicine associated with Shenyang Pharmaceutical University

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Drug(Targets)	Indications	Global Highest Phase

Tongshuan Jiuxin Tablets	Coronary Artery Disease More	Phase 3
Mitoxantrone Hydrochloride ( DNA x Top II )	Stomach Cancer More	Phase 3
Imidol Hydrochloride	Hepatitis B, Chronic More	Phase 2
Demethylcantharidin	Esophageal Carcinoma More	Phase 1
Liposomal docetaxel ( Tubulin )	Non-Small Cell Lung Cancer More	Phase 1

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