Clinical Trial to Evaluate Pharmacokinetics,Safety and Immunogenicity of Single Injection of CDP1 to Healthy Volunteers Compared to Erbitux

NCT ID: NCT03881787

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-27
• Study Completion Date: 2019-12-30

Brief Summary

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.

Detailed Description

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

anti-EGFR monoclonal antibody

Recombinant anti-EGFR human mouse chimeric monoclonal antibody injection 250mg/m2 single administration

Group Type: EXPERIMENTAL

anti-EGFR monoclonal antibody

Intervention Type: DRUG

Recombinant anti-EGFR human mouse chimeric monoclonal antibody injection

Cetuximab

Cetuximab,Erbitux 250mg/m2 single administration

Group Type: ACTIVE_COMPARATOR

Cetuximab injection

Intervention Type: DRUG

Cetuximab injection

Interventions

anti-EGFR monoclonal antibody

Recombinant anti-EGFR human mouse chimeric monoclonal antibody injection

Intervention Type: DRUG

Cetuximab injection

Cetuximab injection

Intervention Type: DRUG

Other Intervention Names

CDP1; Erbitux

Eligibility Criteria

Inclusion Criteria

1. Healthy adult volunteers participate in clinical trials voluntarily and sign informed consent.

2. Age 18 ~ 45 (inclusive) years , male.

3. The body weight is not less than 50 kg, and the body mass index is between 18.5 and 26 (including both ends).

4. Good health, no heart, liver, kidney or other acute or chronic digestive tract diseases, respiratory diseases, blood, endocrine, nervous, mental and other systemic diseases.

5. Physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram and chest X-ray examination are all normal, or the abnormal results of the examination are not clinically meaningful by the investigator.

6. Agree to avoid spouse pregnancy during the trial period and within 6 months after the end of the administration.

Exclusion Criteria

1. Allergic constitution, those who are allergic to the test drug ingredients or have a history of allergies to any drug or food or a history of pollen allergy; those with abnormal serum immunoglobulin E (IgE) (more than 3 times higher than the upper limit of normal).

2. Anti-drug antibody (ADA) positive.

3. Infections currently in need of clinical treatment.

4. HBsAg, HBeAg, HCV-Ab, HIV-Ab or TP-Ab positive.

5. Upon inquiry, there is a clear current medical history of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, metabolic system or other significant diseases.

6. Upon inquiry, a person with a history of mental illness.

7. Upon inquiry, there is a history of cancer and it is judged by the investigator that it is not suitable for participation.

8. According to the investigator's judgment, the investigator believes that it is not suitable for the participants in this clinical trial for various reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

West China Hospital

OTHER

Sponsor Role: collaborator

Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role: collaborator

Dragonboat Biopharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

zheng li, doctor

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

zhu tongyu, doctor

Role: STUDY_DIRECTOR

Shanghai Public Health Clinical Center

Locations

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

West China Hospital

Chengdu, Sichuang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhang Xiaolei, doctor

Role: CONTACT

zhangxiaolei@dragonboatbio.com

(86)021-50276381-637

Wang Qihui, doctor

Role: CONTACT

Qihui.Wang@dragonboatbio.com

(86)021-50276381-301

Facility Contacts

meng xian min, dr

Role: primary

021-37990333

qian ying, Dr

Role: primary

028-85422707

Other Identifiers

CDP100002

Identifier Type: -

Identifier Source: org_study_id