[Translation] A randomized, double-blind, single-dose, parallel comparison of the pharmacokinetic characteristics of humanized anti-VEGF monoclonal antibody injection and bevacizumab injection (Avastin) in healthy Chinese male volunteers

主要研究目的：比较试验药物人源化抗VEGF单抗注射液（规格：100mg/4mL，北京赛升药业股份有限公司生产）和对照药物贝伐珠单抗注射液[Avastin，安维汀，规格： 100mg/4mL，Roche Diagnostics GmbH生产（欧洲来源），北京赛升药业股份有限公司提供]在中国健康男性志愿者以 1mg/kg单次静脉滴注给药的药代动力学（PK）相似性。次要研究目的：评价人源化抗VEGF单抗注射液和贝伐珠单抗注射液（Avastin，安维汀）在中国健康男性志愿者单次静脉滴注给药的安全性、耐受性和免疫原性。

[Translation]

The primary study objective was to compare the pharmacokinetic (PK) similarity of the experimental drug humanized anti-VEGF monoclonal antibody injection (specification: 100 mg/4 mL, produced by Beijing Saisheng Pharmaceutical Co., Ltd.) and the control drug bevacizumab injection [Avastin, specification: 100 mg/4 mL, produced by Roche Diagnostics GmbH (European source), provided by Beijing Saisheng Pharmaceutical Co., Ltd.] in healthy Chinese male volunteers after a single intravenous drip of 1 mg/kg. The secondary study objective was to evaluate the safety, tolerability and immunogenicity of humanized anti-VEGF monoclonal antibody injection and bevacizumab injection (Avastin) in healthy Chinese male volunteers after a single intravenous drip.

Start Date22 Mar 2023

Sponsor / Collaborator

Beijing Lüzhu Biotechnology Co., Ltd.

CTR20171588

/ RecruitingPhase 1

随机双盲平行比较试验药和安维汀在健康男性受试者中单次给药药代动力学、安全性及免疫原性的Ⅰ期临床研究

[Translation] A randomized, double-blind, parallel comparison phase I clinical study on the pharmacokinetics, safety, and immunogenicity of a single-dose trial drug and Avastin in healthy male subjects

评价单次给药后人源化抗VEGF单抗注射液和安维汀主要药代动力学参数（AUC0-t）的相似性。评价单次给药后人源化抗VEGF单抗注射液和安维汀其他PK参数（AUC0-∞、Cmax 、MRT、T1/2、Vd、CL）、安全性和免疫原性的相似性。

[Translation]

To evaluate the similarity of the main pharmacokinetic parameters (AUC0-t) of humanized anti-VEGF monoclonal antibody injection and Avastin after a single dose. To evaluate the similarity of other PK parameters (AUC0-∞, Cmax, MRT, T1/2, Vd, CL), safety and immunogenicity of humanized anti-VEGF monoclonal antibody injection and Avastin after a single dose.

Start Date14 Dec 2017

Sponsor / Collaborator

Beijing Lüzhu Biotechnology Co., Ltd.

EUCTR2014-000272-26-GB

/ Not yet recruitingPhase 3IIT

A Multicentre Phase III Double-masked Randomised Controlled Non-Inferiority Trial comparing the clinical and cost effectiveness of intravitreal therapy with ranibizumab (Lucentis) vs aflibercept (Eylea) vs bevacizumab (Avastin) for Macular Oedema due to Central Retinal Vein Occlusion (CRVO). - LEAVO

Start Date04 Sep 2014

Sponsor / Collaborator

Moorfields Eye Hospital NHS Foundation Trust

100 Clinical Results associated with Bevacizumab(Beijing Science Sun)

100 Translational Medicine associated with Bevacizumab(Beijing Science Sun)

100 Patents (Medical) associated with Bevacizumab(Beijing Science Sun)

100 Deals associated with Bevacizumab(Beijing Science Sun)

External Link

KEGG	Wiki	ATC	Drug Bank
D06409	-	-	DB00112

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Colorectal Carcinoma	Phase 3	China	Beijing Lüzhu Biotechnology Co., Ltd.	31 Jul 2024
Non-Small Cell Lung Cancer	Phase 1	China	Beijing Lüzhu Biotechnology Co., Ltd.	14 Dec 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CSCO2021	Not Applicable	Melanoma	14	化疗联合抗 PD-1 单抗和贝伐珠单抗	(uanopinlkd) = etkviqazmh qdkilzmqew (zcgyxhtdlu ) View more	-	25 Sep 2021
CSCO2020	Not Applicable	Neoplasms	116	长期应用贝伐珠单抗	ssrsakeeyn(fobkehufpj) = jgitmmuazl mnicuduclj (agbtmexnkd ) View more	-	19 Sep 2020
CSCO2020	Not Applicable	EGFR positive Adenocarcinoma of Lung \| Brain metastases	-	奥希替尼联合贝伐珠单抗	djegvlxubk(yehfauucow) = 14.2% vs 11.11% ydesvxvyfh (gyswfocvrc ) View more	-	19 Sep 2020
CSCO2020	Not Applicable	Colorectal Cancer	98	mFOLFOX6联合贝伐珠单抗	(hmintzmoeg) = csesoojkhm jaqbiawcud (xpktzmbxsz ) View more	-	19 Sep 2020
CSCO2020	Not Applicable	Colorectal Cancer	98	常规化疗	(hmintzmoeg) = dkfecbsmtm jaqbiawcud (xpktzmbxsz ) View more	-	19 Sep 2020
CSCO2020	Not Applicable	Ovarian Cancer	30	脂质体多柔比星联合贝伐珠单抗	(adoqincvab) = neefrkntid mqquielzfu (yuorbtujjd ) View more	-	19 Sep 2020

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