A Prospective, Single-Dose, Single-Period Study to Evaluate the Pharmacokinetics and Tolerability of Trinbelimab (Recombinant Anti Rho-D Immunoglobulin) of Bharat Serums and Vaccines Ltd., India in Healthy, Adult, Rhesus-D Negative Non Sensitized Postmenopausal Female Subjects - NIL

开始日期2023-10-15

申办/合作机构

Bharat Serums & Vaccines Ltd.

100 项与 Trinbelimab 相关的临床结果

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100 项与 Trinbelimab 相关的转化医学

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100 项与 Trinbelimab 相关的专利（医药）

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项与 Trinbelimab 相关的文献（医药）

2020-05-15·Obstetrics & Gynecology Science

Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial

Article

作者: Paradkar, Gopalkrishna Vinayak ; Divekar, Ganesh Harishchandra ; Mayekar, Rahul Vishwanath ; Sachan, Rekha ; Sambarey, Pradip Wamanrao ; Bhosale, Archana Anilkumar ; Beeram, Sumalatha ; Patole, Kiran Pandharinath ; Mundle, Shuchita Ramesh ; Md, Rashmi ; John, James ; Trivedi, Yamini ; Daftary, Gautam Vinod ; Anand, Ashok Ramachandra

OBJECTIVETo compare the efficacy and safety of recombinant anti-D (R-anti-D) with conventional polyclonal anti-D (Poly anti-D) in preventing maternal-fetal rhesus D (RhD) alloimmunization and to investigate the immunogenicity of R-anti-D.METHODSThis was a randomized, open-label, multi-center clinical trial conducted in RhD-negative pregnant women who did not receive antenatal anti-D who delivered RhD-positive babies and showed negative indirect Coombs tests (ICTs) at baseline. The women were randomized in a 2:1 ratio to R-anti-D or Poly anti-D groups and were administered 300 mcg (IM) of the corresponding drug within 72 hours of delivery. ICT was performed 72 hours, 90 days, and 180 days after anti-D injection. Serum samples were collected to check for the development of antibodies against R-anti-D at days 90 and 180, using bridging enzyme-linked immunosorbent assay. The proportion of subjects who had positive ICT results at days 90 and 180 were compared between the groups using Fisher's exact test.RESULTSA total of 144 women were randomized to the R-anti-D group and 71 to the Poly anti-D group. Three women in the R-anti-D and none in the Poly anti-D group had a positive ICT result at day 90. No woman in either group had positive ICT result at day 180. Both drugs were well tolerated with only 4 reports of adverse events in each group-all were mild, non-serious, and resolved without sequelae. No subject developed antibodies against R-anti-D.CONCLUSIONThe studied R-anti-D is comparable in efficacy to conventional Poly anti-D and is safe and non-immunogenic.Trial Registration: Clinical Trials Registry of India Identifier: Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2017/03/008101.

2011-08-01·International Journal of Cancer1区 · 医学

Inhibition of ovarian cancer by RGD‐P125A‐endostatin‐Fc fusion proteins

1区 · 医学

Article

作者: Huarui Lu ; Yawu Jing ; Indira V. Subramanian ; Sundaram Ramakrishnan ; Kailang Wu

AbstractPrevious studies have shown that a single point mutation in endostatin at position 125 (P125A) can improve the biological activity of endostatin. Addition of an integrin‐targeting moiety, R‐G‐D, resulted in better localization to tumor vasculature and improved the antiangiogenic activity of endostatin. Because endostatin has relatively shorter serum half‐life, frequent dosing was required for inhibiting tumor growth. In our study, we have genetically fused RGD‐P125A‐endostatin to Fc of IgG4 isotype and evaluated its antiangiogenic and antitumor effects in athymic mice. Two genetic constructs were made, RGD‐P125A‐endostatin‐Fc (RE‐Fc) and P125A‐endostatin‐RGD‐Fc (ER‐Fc). Both constructs were cloned and expressed in mammalian cells. Purified fusion proteins inhibited endothelial cell migration and proliferation better than yeast‐derived P125A‐endostatin. Both RE‐Fc and ER‐Fc inhibited ovarian cancer growth and were found to be as effective as Bevacizumab treatment. Fusion protein showed marked increased half‐life. Combination treatment with Bevacizumab and ER‐Fc showed additive inhibition of ovarian cancer growth. These studies demonstrate that genetic fusion with human IgG4‐Fc increases the half‐life of P125A‐endostatin and can be used along with Bevacizumab to improve antiangiogenic and antitumor activities.

2010-06-01·Ying yong sheng tai xue bao = The journal of applied ecology

[Effects of different rice farming systems on paddy field weed community].

Article

作者: Cheng, Sheng-Kui ; Zhang, Dan ; Liu, Shan ; Jiao, Wen-Jun ; Min, Qing-Wen ; Yang, Hai-Long ; He, Lu

Taking the paddy fields planted with glutinous rice and hybrid rice in the traditional agricultural region in Congjiang County of Guizhou Province as the case, and by using semi-experiment combined with random sampling investigation, this paper studied the characteristics of weed community in the paddy fields under rice monoculture (R), rice-fish culture (R-F), and rice-fish-duck culture (R-F-D). Under the three rice farming systems, glutinous rice had higher capability in inhibiting weeds, compared with hybrid rice. Farming system R-F-D decreased the weed density significantly, with the control effect on Monochoia vaginalis and Rotala indica being 100%. The overall weed-inhibiting effect of R-F-D was significantly higher than that of the other farming systems. Under R-F-D, the species richness and Shannon diversity index of weed community decreased markedly, while the Pielou evenness index increased, indicating that the species composition of weed community changed greatly, and the occurrence of native dominant weed species decreased. It was concluded that R-F-D was a feasible farming system for the control of paddy field weed community.

100 项与 Trinbelimab 相关的药物交易

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