[Translation] A clinical study comparing the pharmacokinetic similarity and safety evaluation of A168 injection and ramucirumab in healthy male subjects

主要目的：评价A168与雷莫芦单抗（商品名：CYRAMZA）在健康男性受试者单次静脉给药的药代动力学（PK）相似性。次要目的：评价A168与CYRAMZA在健康男性受试者单次静脉给药的安全性和耐受性；评价A168与CYRAMZA在健康男性受试者单次静脉给药的免疫原性。

[Translation]

Primary objective: To evaluate the pharmacokinetic (PK) similarity of A168 and ramucirumab (trade name: CYRAMZA) in healthy male subjects after a single intravenous administration. Secondary objectives: To evaluate the safety and tolerability of A168 and CYRAMZA in healthy male subjects after a single intravenous administration; To evaluate the immunogenicity of A168 and CYRAMZA in healthy male subjects after a single intravenous administration.

Start Date20 Sep 2019

Sponsor / Collaborator

Sichuan Kelun Botai Biomedicine Co., Ltd.

CTR20181485

/ CompletedPhase 1

抗VEGFR2单抗在晚期实体瘤患者中的安全性、耐受性及药代动力学特征的Ⅰ期临床研究

[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetic characteristics of anti-VEGFR2 monoclonal antibody in patients with advanced solid tumors

1）评估重组抗VEGFR2全人源单克隆抗体注射液在晚期实体瘤患者中的安全性和耐受性； 2）确定重组抗VEGFR2全人源单克隆抗体注射液单药治疗晚期实体瘤患者的剂量限制性毒性（DLT）、最大耐受剂量（MTD）及Ⅱ期推荐剂量（RP2D）。

[Translation]

1) To evaluate the safety and tolerability of recombinant anti-VEGFR2 fully human monoclonal antibody injection in patients with advanced solid tumors; 2) To determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of recombinant anti-VEGFR2 fully human monoclonal antibody injection as a monotherapy for patients with advanced solid tumors.

Start Date23 May 2018

Sponsor / Collaborator

Sichuan Kelun Botai Biomedicine Co., Ltd.

100 Clinical Results associated with Ramucirumab biosimilar (Sichuan Kelun Pharma)

100 Translational Medicine associated with Ramucirumab biosimilar (Sichuan Kelun Pharma)

100 Patents (Medical) associated with Ramucirumab biosimilar (Sichuan Kelun Pharma)

100 Deals associated with Ramucirumab biosimilar (Sichuan Kelun Pharma)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC21	-

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Colorectal Cancer	Phase 1	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	20 Sep 2019
Non-Small Cell Lung Cancer	Phase 1	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	20 Sep 2019
Stomach Cancer	Phase 1	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	20 Sep 2019
Advanced Malignant Solid Neoplasm	Phase 1	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	23 May 2018

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