Double-blind Randomized Comparative, in Parallel Groups, Clinical Study of Pharmacokinetics and Safety of Drugs RPH-001 (JSC R-Pharm, Russia) and Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) in Single Intravenous Administration in Healthy Volunteers

The purpose of this study is to confirm pharmacokinetic equivalence and compare clinical safety profile of RPH-001 and Avastin®.

开始日期2018-07-10

申办/合作机构

R-Pharm JSC

[+1]

NCT03131700 / Withdrawn临床1期

Phase I, Double Blind, Randomized, Parallel-Arm, Single-Dose, Bioequivalence and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator (Avastin®, Roche) in Healthy Male Volunteers

The purpose of this to assess pharmacokinetic bioequivalence between two bevacizumab products, RPH-001 (TRPHARM) and EU sourced Avastin® (Roche), after single IV administration at 5 mg/kg fixed dose.

开始日期2017-12-01

申办/合作机构

TRPHARM Ilaç Sanayi Tic. AS

100 项与贝伐珠单抗生物类似药 (苏州康宁杰瑞) 相关的临床结果

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100 项与贝伐珠单抗生物类似药 (苏州康宁杰瑞) 相关的转化医学

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100 项与贝伐珠单抗生物类似药 (苏州康宁杰瑞) 相关的专利（医药）

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项与贝伐珠单抗生物类似药 (苏州康宁杰瑞) 相关的文献（医药）

2021-10-01·Viral Immunology4区 · 医学

Induction of Immune Responses by Recombinant PH-1 Domain of Infectious Laryngotracheitis Virus Glycoprotein B in Chickens

4区 · 医学

Article

作者: Mohammad Majid, Ebrahimi ; Shahla, Shahsavandi ; Samireh, Faramarzi

Infectious laryngotracheitis virus (ILTV) is a cause of main respiratory disease of chickens controlled through live attenuated vaccines. To reduce the risk of adverse effects associated with live vaccines, a recombinant vaccine expressing PH-1 domain of viral glycoprotein B was constructed using the pET expression system under isopropylthiogalactoside (IPTG) induction. The potential immunogenicity of recombinant PH-1 (rPH-1) was evaluated in chickens. Eight-week-old specific-pathogen-free chickens were intramuscularly administered two doses of rPH-1, 25 and 50 μg, alone or with a combination of ISA70 adjuvant. The humoral immune responses were determined up to 3 months postvaccination at 2 weeks apart. The T cell proliferation response was determined on day 28 after primary immunization. The vaccinated birds with rPH-1/ISA70 developed higher and constant-specific anti-ILTV enzyme-linked immunosorbent assay (ELISA) antibodies than in those vaccinated with rPH-1 alone. Coinjection of rPH-1 and adjuvant significantly (p < 0.01) increased the T cell proliferation responses. There were no significant differences in eliciting the immune responses in chickens immunized with the higher dose of the antigen than that with the lower dose. The data indicate the immunogenic efficiency of rPH-1 against ILTV. Vaccination with recombinant proteins offers a preventing option to control the ILTV infection and could be a candidate to replace current live vaccines.

1983-01-01·Pathology3区 · 医学

A unique T-cell monoclonal antibody with potential uses in autologous bone marrow transplantation

3区 · 医学

Article

作者: R.E. Davis ; Brian F. Meyer ; V.M. Chugg ; R.P. Herrmann

A monoclonal antibody reactive with an antigen expressed by a T-cell subset has been produced. The antibody designated RPH-1 reacts with a subset of normal T-cells and thymocytes. The antibody was strongly reactive with blast cells from 3 patients with T-acute lymphoblastic leukemia (T-ALL) and also reacted with cells of 2 patients with non-T-ALL. The antibody did not react with leukemic cells from patients with acute myeloid leukemia (AML) or B-chronic lymphocytic leukemia (B-CLL)). RPH-1 reacted with 2 T-cell lines, no B-cell lines and no myeloid cell lines. Absence of toxicity to granulocyte macrophage colony forming units (CFU-GM) by RPH-1 in the presence of complement was demonstrated, and in view of strong reactivity with certain leukemic cells, potential application of RPH-1 as an immunological means of selectively removing tumour cells is indicated.

100 项与贝伐珠单抗生物类似药 (苏州康宁杰瑞) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC07	-

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
乳腺癌	临床3期	俄罗斯	R-Pharm Group	-
结直肠癌	临床3期	俄罗斯	R-Pharm Group	-
结直肠癌	临床3期	中国	苏州康宁杰瑞生物科技有限公司	-