Healthy Volunteers Clinical Trial
Official title:
Clinical Trial to Evaluate Pharmacokinetics,Safety and Immunogenicity of Single Injection of Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) to Healthy Volunteers Compared to Erbitux
Background Colorectal cancer (CRC) is one of the most common human malignant tumors. The
incidence and mortality of colorectal cancer in our country are on the rise. Surgery-based,
combined with chemotherapy, radiotherapy comprehensive treatment, is the main treatment of
colorectal cancer. Surgical resection has been recognized as the primary treatment of
colorectal cancer. However, due to the majority of patients already advanced at the time of
diagnosis, some difficulties are brought to radical surgery. Therefore, the importance of
chemotherapy for colorectal cancer gradually been clinically recognized, But rarely survive
more than 18 months." In addition to chemotherapy, there is now a more ideal model of cancer
treatment- molecular targeted therapies, including monoclonal antibody drugs such as
cetuximab, as well as small molecule tyrosine kinases Inhibitors gefitinib and so on.
Molecular targeted drugs make use of the difference in molecular biology between tumor cells
and normal cells. Targeting drugs to tumor cells and inhibiting the growth and proliferation
of the cells can achieve the therapeutic effect, which has the advantages of high specificity
and low adverse reaction. The bio-targeted drug cetuximab is the first drug approved to
marketed as an epidermal growth factor receptor (EGFR)-targeting immunoglobulin
1（IgG1）monoclonal antibody. Cetuximab, either monotherapy or combined radiotherapy and
chemotherapy, can exert excellent anti-tumor activity in EGFR-positive malignant tumors and
can significantly enhance the efficacy of radiotherapy and chemotherapy.
Reference to cetuximab injection, guilin sanjin Co., Ltd. and dragonboat Co., Ltd. jointly
developed a recombinant anti-EGFR human mouse chimeric monoclonal antibody (R & D code:
CDP1).The primary structure of CDP1 is exactly the same with cetuximab, the higher structure
and Physical and chemical properties and cetuximab are highly similar. Pharmacodynamic
activity in vivo and in vitro, pharmacokinetic characteristics and toxicological reactions
are also similar to cetuximab. CDP1 selected with cetuximab consistent formulations,
prescriptions, specifications.
CDP1 was approved by China Food and Drug Administration (No. 2016L06884) in August 2016 for
clinical studies. According to the contents of the document and guidelines for biological
analogs, the clinical pharmacokinetic and clinical effectiveness comparison tests of CDP1 and
the safety and immunogenicity assessment are planned.
OBJECTIVES:
Primary:
To compare the pharmacokinetic characteristics of a single dose between CDP1 and the original
drug Erbitux in healthy volunteers.
Secondary :
To compare the safety and immunogenic characteristics of the single dose between CDP1 and the
original drug Erbitux in healthy volunteers.
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