A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects

This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects. This study is divided into two parts.

Start Date22 Apr 2024

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

CTR20210716

/ CompletedPhase 1

单中心、随机、双盲、平行对照比较重组抗EGFR人鼠嵌合单克隆抗体注射液（JZB29）与爱必妥®在健康受试者中的药代动力学、安全性和免疫原性的 I 期临床研究

[Translation] A single-center, randomized, double-blind, parallel-controlled phase I clinical study comparing the pharmacokinetics, safety and immunogenicity of a recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection (JZB29) and Erbitux® in healthy subjects

主要研究目的：评价重组抗EGFR人鼠嵌合单克隆抗体注射液（JZB29）与爱必妥®在健康受试者中的药代动力学特征。次要研究目的：评价重组抗EGFR人鼠嵌合单克隆抗体注射液（JZB29）与爱必妥®在健康受试者体内的安全性和免疫原性特征。

[Translation]

The primary study objective is to evaluate the pharmacokinetic characteristics of recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection (JZB29) and Erbitux® in healthy subjects. The secondary study objective is to evaluate the safety and immunogenicity characteristics of recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection (JZB29) and Erbitux® in healthy subjects.

Start Date06 May 2021

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

CTR20170709

/ CompletedPhase 1

重组抗EGFR人鼠嵌合单克隆抗体在中国晚期复发转移性结直肠癌患者中的安全性和药代动力学研究

[Translation] Safety and pharmacokinetics of recombinant anti-EGFR human-mouse chimeric monoclonal antibody in Chinese patients with advanced recurrent metastatic colorectal cancer

评价晚期复发转移性结直肠癌患者多次静脉滴注重组抗EGFR人鼠嵌合单克隆抗体的安全性和药代动力学及免疫原性，比较与西妥昔单抗是否具有临床药理学相似性，为后期临床试验的方案设计提供依据。

[Translation]

To evaluate the safety, pharmacokinetics and immunogenicity of multiple intravenous infusions of recombinant anti-EGFR human-mouse chimeric monoclonal antibodies in patients with advanced recurrent metastatic colorectal cancer, and to compare their clinical pharmacology with cetuximab, so as to provide a basis for the design of later clinical trials.

Start Date07 Aug 2017

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

100 Clinical Results associated with Cetuximab biosimilar(Shanghai Henlius Biotech, Inc.)

100 Translational Medicine associated with Cetuximab biosimilar(Shanghai Henlius Biotech, Inc.)

100 Patents (Medical) associated with Cetuximab biosimilar(Shanghai Henlius Biotech, Inc.)

100 Deals associated with Cetuximab biosimilar(Shanghai Henlius Biotech, Inc.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC06	-

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Squamous cell carcinoma of head and neck metastatic	Phase 2	China	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	30 Jan 2023
Squamous Cell Carcinoma of Head and Neck	Phase 1	China	Shanghai Henlius Biotech, Inc.	04 Sep 2018
Metastatic Colorectal Carcinoma	Phase 1	China	Shanghai Henlius Biotech, Inc.	07 Aug 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis