Healthy VolunteersPhase 1NCT03881787
Clinical Trial to Evaluate Pharmacokinetics,Safety and Immunogenicity of Single Injection of CDP1 to Healthy Volunteers Compared to Erbitux
A Phase 1 study testing anti-EGFR monoclonal antibody and Cetuximab injection in people with Healthy Volunteers, run by Dragonboat Biopharmaceutical Company Limited at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- anti-EGFR monoclonal antibody and Cetuximab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesChina
- Study dates
- 19 Apr 2017to 19 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers participate in clinical trials voluntarily and sign informed consent.
- Age 18 ~ 45 (inclusive) years , male.
- The body weight is not less than 50 kg, and the body mass index is between 18.5 and 26 (including both ends).
- Good health, no heart, liver, kidney or other acute or chronic digestive tract diseases, respiratory diseases, blood, endocrine, nervous, mental and other systemic diseases.
- 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.
- Agree to avoid spouse pregnancy during the trial period and within 6 months after the end of the administration.
Who cannot join
- 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).
- Anti-drug antibody (ADA) positive.
- Infections currently in need of clinical treatment.
- HBsAg, HBeAg, HCV-Ab, HIV-Ab or TP-Ab positive.
- 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.
- Upon inquiry, a person with a history of mental illness.
- Upon inquiry, there is a history of cancer and it is judged by the investigator that it is not suitable for participation.
- According to the investigator's judgment, the investigator believes that it is not suitable for the participants in this clinical trial for various reasons.
Trial locations and contacts
2 sites in 1 country.
China2 sites
West China Hospital
Chengdu, Sichuang
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality
About this study
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.
Read the 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
- Being tested
- anti-EGFR monoclonal antibody, Cetuximab injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-EGFR monoclonal antibodyDrug
Also called CDP1
Recombinant anti-EGFR human mouse chimeric monoclonal antibody injection
Cetuximab injectionDrug
Also called Erbitux
Cetuximab injection
| Study group | Role | What they receive |
|---|---|---|
| anti-EGFR monoclonal antibody | Experimental | Recombinant anti-EGFR human mouse chimeric monoclonal antibody injection 250mg/m2 single administration Receives: Drug: anti-EGFR monoclonal antibody |
| Cetuximab | Active comparator | Cetuximab,Erbitux 250mg/m2 single administration Receives: Drug: Cetuximab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameters: Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Infusion
AUC(0-t) for CDP1
Measured: Up to 22 Days
Secondary outcomes (12)
Pharmacokinetic parameters: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-00) After Infusion
Pharmacokinetic parameters: AUC(0-00) for CDP1
Measured: Up to 22 Days
Pharmacokinetic parameters: Observed Maximum Serum Concentration (Cmax) of CDP1 After Infusion
Pharmacokinetic parameters Cmax for CDP1
Measured: Up to 22 Days
Pharmacokinetic parameters: Mean Residence Time of Drug in the Body (MRT) of CDP1 After Infusion
Pharmacokinetic parameters MRT for CDP1
Measured: Up to 22 Days
Pharmacokinetic parameters: Apparent Terminal Half-life (t1/2) of CDP1 After Infusion
Pharmacokinetic parameters T1/2 for CDP1
Measured: Up to 22 Days
Pharmacokinetic parameters: Total Body Clearance of Drug From Serum (CL) After Infusion
Pharmacokinetic parameters CL for CDP1
Measured: Up to 22 Days
Vital signs: Blood pressure
Vital signs: Blood pressure
Measured: Up to 29 Days
Vital signs: Pulse rate
Vital signs: Pulse rate
Measured: Up to 29 Days
Vital signs: Respiratory rate
Vital signs: Respiratory rate
Measured: Up to 29 Days
Physical examination: Weigh
Physical examination: Weigh
Measured: Up to 29 Days
Frequency of adverse events (AE)
Frequency of adverse events (AE)
Measured: Up to 29 Days
Immunogenicity indicators: Anti-drug antibodies (ADA)
Immunogenicity indicators: Anti-drug antibodies (ADA)
Measured: Up to 29 Days
Immunogenicity indicators: neutralizing antibodies
Immunogenicity indicators: neutralizing antibodies
Measured: Up to 29 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start19 Apr 2017
- Primary completion19 Aug 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dragonboat Biopharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital, Shanghai Public Health Clinical Center
- Responsible party
- Sponsor
- Investigators
- zheng li, doctor, Principal investigator, West China Hospitalzhu tongyu, doctor, Study director, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881787
- Sponsor's protocol ID
- CDP100002
- Status last verified
- Aug 2019
- First submitted
- 18 Mar 2019
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03881787
- Acronym / sponsor ID
- CDP100002
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Dragonboat Biopharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- West China Hospital, Shanghai Public Health Clinical Center
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti-EGFR monoclonal antibody | Experimental | Drug: anti-EGFR monoclonal antibodyRecombinant anti-EGFR human mouse chimeric monoclonal antibody injection 250mg/m2 single administration |
| Cetuximab | Active comparator | Drug: Cetuximab injectionCetuximab,Erbitux 250mg/m2 single administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult volunteers participate in clinical trials voluntarily and sign informed consent.
- Age 18 ~ 45 (inclusive) years , male.
- The body weight is not less than 50 kg, and the body mass index is between 18.5 and 26 (including both ends).
- Good health, no heart, liver, kidney or other acute or chronic digestive tract diseases, respiratory diseases, blood, endocrine, nervous, mental and other systemic diseases.
- 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.
Key exclusion criteria (8 listed)
- 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).
- Anti-drug antibody (ADA) positive.
- Infections currently in need of clinical treatment.
- HBsAg, HBeAg, HCV-Ab, HIV-Ab or TP-Ab positive.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-EGFR monoclonal antibodyAlso: CDP1Recombinant anti-EGFR human mouse chimeric monoclonal antibody injection | Drug | anti-EGFR monoclonal antibody |
| Cetuximab injectionAlso: ErbituxCetuximab injection | Drug | Cetuximab |
Primary outcome
Pharmacokinetic Parameters: Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Infusion
Time frame: Up to 22 Days
AUC(0-t) for CDP1
12 secondary outcomes
Pharmacokinetic parameters: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-00) After Infusion
Time frame: Up to 22 Days
Pharmacokinetic parameters: Observed Maximum Serum Concentration (Cmax) of CDP1 After Infusion
Time frame: Up to 22 Days
Pharmacokinetic parameters: Mean Residence Time of Drug in the Body (MRT) of CDP1 After Infusion
Time frame: Up to 22 Days
Pharmacokinetic parameters: Apparent Terminal Half-life (t1/2) of CDP1 After Infusion
Time frame: Up to 22 Days
Pharmacokinetic parameters: Total Body Clearance of Drug From Serum (CL) After Infusion
Time frame: Up to 22 Days
Vital signs: Blood pressure
Time frame: Up to 29 Days
Vital signs: Pulse rate
Time frame: Up to 29 Days
Vital signs: Respiratory rate
Time frame: Up to 29 Days
Physical examination: Weigh
Time frame: Up to 29 Days
Frequency of adverse events (AE)
Time frame: Up to 29 Days
Immunogenicity indicators: Anti-drug antibodies (ADA)
Time frame: Up to 29 Days
Immunogenicity indicators: neutralizing antibodies
Time frame: Up to 29 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zheng li, doctor principal investigator
West China Hospital
zhu tongyu, doctor study director
Shanghai Public Health Clinical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anti-EGFR monoclonal antibody and Cetuximab injection in people with Healthy Volunteers, run by Dragonboat Biopharmaceutical Company Limited at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Parameters: Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Infusion (time frame: Up to 22 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.