[Translation] Clinical trial on the pharmacodynamics of recombinant human hyaluronidase for injection as an adjunct to subcutaneous infusion in healthy subjects

主要目的：评价注射用重组人透明质酸酶在健康受试者中辅助皮下输液的药效学特征。次要目的：评价注射用重组人透明质酸酶在健康受试者中的药效学特征、安全性、免疫原性。

[Translation]

Primary objective: To evaluate the pharmacodynamic characteristics of recombinant human hyaluronidase for injection as an adjunct to subcutaneous infusion in healthy subjects. Secondary objective: To evaluate the pharmacodynamic characteristics, safety, and immunogenicity of recombinant human hyaluronidase for injection in healthy subjects.

Start Date28 Mar 2024

Sponsor / Collaborator

Suzhou Kangju BIOTECHNOLOGY Co., Ltd.

[+1]

CTR20210453 / CompletedPhase 3

注射用重组人透明质酸酶在中国健康受试者中辅助皮下输液的药效学研究

[Translation] Pharmacodynamic study of recombinant human hyaluronidase for injection as an adjunct to subcutaneous infusion in healthy Chinese subjects

主要目的：以皮下输液的速率为指标，评价注射用重组人透明质酸酶在健康受试者中自身对照单次给药辅助皮下输液的药效学特征；次要目的：以受试者臂围的测量值为指标，评价注射用重组人透明质酸酶在健康受试者中自身对照单次给药辅助皮下输液的药效学特征；评价注射用重组人透明质酸酶在健康受试者中自身对照单次给药辅助皮下输液的安全性和免疫原性。

[Translation]

Primary purpose: To evaluate the pharmacodynamic characteristics of a single self-controlled subcutaneous infusion of recombinant human hyaluronidase for injection in healthy subjects, using the rate of subcutaneous infusion as an indicator; Secondary purpose: To evaluate the pharmacodynamic characteristics of a single self-controlled subcutaneous infusion of recombinant human hyaluronidase for injection in healthy subjects, using the measured arm circumference of the subjects as an indicator; Evaluate the safety and immunogenicity of a single self-controlled subcutaneous infusion of recombinant human hyaluronidase for injection in healthy subjects.

Start Date04 Aug 2021

Sponsor / Collaborator

Suzhou Kangju BIOTECHNOLOGY Co., Ltd.

[+1]

ChiCTR2100047902 / RecruitingPhase 4IIT

Study on the efficiency of dexmedetomidine in endobronchial ultrasound-guided transbronchial needle aspiration

Start Date01 Apr 2021

Sponsor / Collaborator-

100 Clinical Results associated with Drug adjuvant

100 Translational Medicine associated with Drug adjuvant

0 Patents (Medical) associated with Drug adjuvant

432

Literatures (Medical) associated with Drug adjuvant

01 Apr 2024·The International Journal of Biochemistry & Cell Biology

Xuetongsu attenuates bone destruction in collagen-induced arthritis mice by inhibiting osteoclast differentiation and promoting osteoclast apoptosis

Article

Author: Deng, Yasi ; Sheng, Wenbing ; Yang, Yong ; Shen, Xinyang ; Wang, Wei ; Yu, Huanghe ; Yuan, Hanwen ; Zheng, Hao ; Li, Huanjie ; Lin, Haokai ; Tian, Xing ; Li, Bin ; Li, Yunzhe

Tujia ethnomedicine Xuetong (the stems of Kadsura heteroclita) have been widely used in folk for rheumatoid arthritis (RA), which can alleviate rheumatic pain through liquor soaking in folk. In this study, we aimed to evaluate the pharmacological effects and underlying mechanism of Xuetongsu (a key chemical component of Xuetong) on bone destruction. In our previous study, it was found that Xuetong extract can reduce adjuvant arthritic rats paw swelling and inhibit inflammatory factors in serum. Furthermore, Xuetongsu has been demonstrated to inhibit the proliferation of fibroblast-like synoviocytes, but its potential to inhibit bone destruction has not been explored. To address this, we employed the STRING database to predict protein interactions and utilized Autodock software to simulate the binding of Xuetongsu to target proteins. In this study, administration of Xuetongsu significantly alleviated paw swelling and bone destruction in C57BL/6 mice with collagen-induced arthritis (CIA). Mechanistic studies have indicated that Xuetongsu promotes apoptosis of mature osteoclasts in joint tissues by activating Caspase-3 and Bax, while inhibiting Bcl-2. Additionally, Xuetongsu inhibits osteoclast differentiation by suppressing RANKL, RANK, P-NF-κB, and NFATc1, and reduces bone resorption activity by inhibiting MMP-9, CTSK, and TRAP. Importantly, Xuetongsu exhibits good biocompatibility in major organs of mice. In summary, Xuetongsu has the potential to treat bone destruction by promoting apoptosis of mature osteoclasts, inhibiting osteoclast differentiation, and reducing bone resorption. This study reveals the pharmacological effects of Xuetongsu and its mechanism of action, which may contribute to the development of novel approaches for treating RA.

01 Feb 2024·Inflammopharmacology

Galantamine mitigates testicular injury and disturbed spermatogenesis in adjuvant arthritic rats via modulating apoptosis, inflammatory signals, and IL-6/JAK/STAT3/SOCS3 signaling

Article

Author: Shafiey, Sara I ; Ahmed, Kawkab A ; Mohamed, Wafaa R ; Abo-Youssef, Amira M ; Abo-Saif, Ali A

AbstractRheumatoid arthritis (RA) affects the joints and the endocrine system via persistent immune system activation. RA patients have a higher frequency of testicular dysfunction, impotence, and decreased libido. This investigation aimed to evaluate the efficacy of galantamine (GAL) on testicular injury secondary to RA. Rats were allocated into four groups: control, GAL (2 mg/kg/day, p.o), CFA (0.3 mg/kg, s.c), and CFA + GAL. Testicular injury indicators, such as testosterone level, sperm count, and gonadosomatic index, were evaluated. Inflammatory indicators, such as interleukin-6 (IL-6), p-Nuclear factor kappa B (NF-κB p65), and anti-inflammatory cytokine interleukin-10 (IL-10), were assessed. Cleaved caspase-3 expression was immunohistochemically investigated. Protein expressions of Janus kinase (JAK), signal transducers and activators of transcription (STAT3), and Suppressors of Cytokine Signaling 3 (SOCS3) were examined by Western blot analysis. Results show that serum testosterone, sperm count, and gonadosomatic index were increased significantly by GAL. Additionally, GAL significantly diminished testicular IL-6 while improved IL-10 expression relative to CFA group. Furthermore, GAL attenuated testicular histopathological abnormalities by CFA and downregulated cleaved caspase-3 and NF-κB p65 expressions. It also downregulated JAK/STAT3 cascade with SOCS3 upregulation. In conclusion, GAL has potential protective effects on testicular damage secondary to RA via counteracting testicular inflammation, apoptosis, and inhibiting IL-6/JAK/STAT3/SOCS3 signaling.Graphical abstract

01 Jul 2023·Journal of Trace Elements in Medicine and Biology

L-carnitine and Zinc supplementation impedes intestinal damage in methotrexate-treated adjuvant-induced arthritis rats: Reinstating enterocyte proliferation and trace elements

Article

Author: Katturajan, Ramkumar ; Evan Prince, Sabina

BACKGROUNDMethotrexate (MTX), a folic acid analogue, is used as a first-line treatment for rheumatoid arthritis (RA) since it has more therapeutic mechanisms than any other drug. Being an undeniable drug for the treatment of arthritis, even low-dose MTX provokes intestinal toxicity as a primary adverse effect and does not revive an anti-inflammatory element. Thus, our study aims to elucidate the anti-arthritic and prophylactic activity of supplements L-carnitine (L) and zinc (Z) against MTX-mediated intestinal damage in arthritis rats.METHODSThe rats were assessed for arthritic parameters such as body weight, paw volume, x-ray scan, and serum trace elements level. To analyze the toxic effects of MTX in the rats, intestine pH, mucosal weight, digestive enzymes, myeloperoxidase, histopathological, and immunohistochemical analysis were performed.RESULTSOur study demonstrated that the arthritic parameters have shown that MTX has an ameliorative effect on arthritic rats. Besides, our findings showed that low-dose MTX (2.5 mg/kg b.w.) given once a week for two weeks during arthritis treatment had toxic effects in the rat's intestine, as evidenced by changes in intestine pH and mucosal weight, decreased digestive enzymes, increased MPO, and degenerative changes in histopathological analysis. Concurrent therapy of LZ with MTX, on the other hand, restored the modifications in these parameters.CONCLUSIONMTX in combination with LZ effectively manages arthritis than monotherapy and significantly prevents MTX-induced intestinal damage in arthritis rats. Thus, LZ could be used as an improved therapeutic and safety for MTX-instigated intestinal damage during arthritis treatments. Therefore, our combination of L-carnitine and zinc with MTX would be promising prophylactic activity for arthritis patients.

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