Gastric CancerPhase 1NCT05800418
Clinical Study to Compare the Pharmacokinetics and Safety of Ramucirumab Injection With Cyramza ® in Healthy Male Volunteers
A Phase 1 study testing Ramucirumab Injection and Ramucirumab Injection [Cyramza] in people with Gastric Cancer and Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
Ramucirumab is a biosimilar drug of CYRAMZA® produced by Chiatai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., LTD. It is a vascular endothelial growth factor receptor 2 (VEGFR-2) antagonist. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Non-small Cell Lung Cancer, Colo-rectal Cancer
- What is being tested?
- Ramucirumab Injection and Ramucirumab Injection [Cyramza]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2019to 18 Feb 2020
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign informed consent form before the study and fully understand the study content, process and possible adverse reactions;
- Be able to complete the study according to the requirements of the test plan;
- Male subjects aged 18-65 years (included);
- The subject should weigh at least 50kg. Body mass index (BMI) = weight (kg)/ height2(m2), BMI in the range of 19 to 26 (included);
- Health status: no mental abnormality, no medical history of abnormal cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolism;
- Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram and imaging examination with no clinical significance;
- Have no pregnancy plan and voluntarily take effective contraception measures from 2 weeks before the study drug administration to at least 6 months after the last dose.
Who cannot join
- Have a history of neuropsychiatric system, respiratory system, cardiovascular system, digestive system, hemolymph system, liver and kidney insufficiency, endocrine system, skeletal and musculoskeletal system disease or other diseases, and the investigators judge that this history may affect drug metabolism or safety;
- Known allergic to Ramucirumab or its excipients; Known history of allergic diseases or allergic constitution;
- History of hypertension or abnormal blood pressure at screening/baseline measurement (systolic blood pressure (SBP) > 140 mmHg, and/or diastolic blood pressure (DBP) >90 mmHg, confirmed by one repeat measurement on the same day);
- A history of clinically significant albuminuria (urine routine examination, albuminuria 2+ and above) or albuminuria as assessed by the investigator;
- Had received treatment of Ramucirumab or VEGFR2 receptor antagonist, or other antibody or protein drugs that target VEGFR2 receptor;
- Had received any live viral vaccine within 2 months prior to study drug infusion, or required vaccination between the screening period and the end of the study, had used any monoclonal antibody or biologic drug within 12 months prior to study drug administration, or planned to receive any monoclonal antibody or biologic drug within 12 months after study drug administration;
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- had unhealed wound ulcers or fractures, or had undergone major surgery within 3 months prior to study drug infusion or expected to undergo major surgery during the study period or within 2 months after study completion;
- had taken any prescription drugs, over-the-counter drugs, any vitamin products, or herbs within 14 days prior to use of the study drug;
- Patients with abnormal examinations and clinical significance during the screening period;
- Blood donation or significant blood loss within 3 months prior to use of the study drug (>450 mL);
- Have taken the study drug or participated in any clinical trial of the drug within 3 months prior to the use of the study drug;
- Smokers who smoked more than 5 cigarettes a day in the 3 months before the test;
- Test positive for alcohol or have a history of alcohol abuse (14 units of alcohol per week: 1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine);
- Test positive for drugs or have a history of drug abuse in the past five years or have used drugs in the three months prior to the test;
- Hepatitis (including hepatitis B and C), AIDS, syphilis positive screening;
- Patients with difficulty in venous blood collection or who cannot tolerate venipuncture;
- Unable or unable to comply with ward management regulations, poor compliance during the study, or unable to follow protocol requirements to complete the study;
- Subjects unable to complete the experiment due to personal reasons;
- Conditions considered unsuitable for inclusion by other researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, 130021
About this study
Official title: Phase I Clinical Study of Single-center, Randomized, Double-blind, Single-dose, Parallel Comparison of the Pharmacokinetics and Safety of Ramucirumab Injection and Cyramza® in Healthy Male Volunteers
Ramucirumab is a biosimilar drug of CYRAMZA® produced by Chiatai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., LTD. It is a vascular endothelial growth factor receptor 2 (VEGFR-2) antagonist. This single-center, randomized, double-blind, single-dose, parallel phase I study of Ramucirumab injection versus Cyramza ® in healthy male volunteers was designed to evaluate the similarities in pharmacokinetics, tolerance, safety and immunogenicity of Ramucirumab and CYRAMZA®.
- Being tested
- Ramucirumab Injection, Ramucirumab Injection [Cyramza]
- Medical subject headings
- Stomach Neoplasms, Carcinoma, Non-Small-Cell Lung, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramucirumab InjectionDrug
Ramucirumab injection biosimilar products manufactured by Chia Tai Tianqing Pharmaceutical,
Ramucirumab Injection [Cyramza]Drug
Ramucirumab Injection is a humanized monoclonal antibody based on the human immunoglobulin G1(IgG1) skeleton sequence, developed by Eli Lilly Co., the bran name is Cyramza. Ramucirumab is a vascular endothelial growth factor receptor 2 (VEGFR2) antagonist that specifically binds to VEGF receptor 2 and blocks VEGFR ligand, VEGF-A, VEGF-C, and VEGF-D binding to the receptor. As a result, Ramucirumab inhibits ligand-stimulated VEGF receptor 2 activation, thereby inhibiting ligand-induced proliferation, and human endothelial cell migration. Ramucirumab inhibits angiogenesis, thereby blocking the tumor's blood vessel supply.
| Study group | Role | What they receive |
|---|---|---|
| Ramucirumab injection | Experimental | 8mg/kg, Single intravenous infusion Receives: Drug: Ramucirumab Injection |
| Cyramza | Active comparator | 8mg/kg, Single intravenous infusion Receives: Drug: Ramucirumab Injection [Cyramza] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under drug concentration - time curve (AUC0-t)
Area under the curve from zero to the lowest detectable blood drug concentration.
Measured: Within 60 minutes before administration to 1680 hours after administration.
Secondary outcomes (6)
Area under drug concentration - time curve (AUC0-∞)
The area under the curve extrapolating from zero to infinity.
Measured: Within 60 minutes before administration to 1680 hours after administration.
Peak concentration (Cmax)
Peak maximum plasma drug concentration
Measured: Within 60 minutes before administration to 1680 hours after administration.
Peak concentration time (Tmax)
Time to reach maximum plasma concentration after dosing
Measured: Within 60 minutes before administration to 1680 hours after administration.
Clearance rate (CL)
Percentage of the organ-scavenging drugs that eliminated by the body
Measured: Within 60 minutes before administration to 1680 hours after administration.
Half-life (T1/2)
The time it takes for serum drug concentrations to drop by half
Measured: Within 60 minutes before administration to 1680 hours after administration.
Apparent volume of distribution (Vd)
Apparent volume of distribution after administration
Measured: Within 60 minutes before administration to 1680 hours after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start4 Nov 2019
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800418
- Sponsor's protocol ID
- ZDTQ-2019-LMLDK
- Status last verified
- Oct 2019
- First submitted
- 24 Mar 2023
- Last updated
- 5 Apr 2023
- 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 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of Single-center, Randomized, Double-blind, Single-dose, Parallel Comparison of the Pharmacokinetics and Safety of Ramucirumab Injection and Cyramza® in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT05800418
- Acronym / sponsor ID
- ZDTQ-2019-LMLDK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 5 Apr 2023 (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.
Ramucirumab is a biosimilar drug of CYRAMZA® produced by Chiatai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., LTD. It is a vascular endothelial growth factor receptor 2 (VEGFR-2) antagonist. This single-center, randomized, double-blind, single-dose, parallel phase I study of Ramucirumab injection versus Cyramza ® in healthy male volunteers was designed to evaluate the similarities in pharmacokinetics, tolerance, safety and immunogenicity of Ramucirumab and CYRAMZA®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ramucirumab injection | Experimental | Drug: Ramucirumab Injection8mg/kg, Single intravenous infusion |
| Cyramza | Active comparator | Drug: Ramucirumab Injection [Cyramza]8mg/kg, Single intravenous infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Sign informed consent form before the study and fully understand the study content, process and possible adverse reactions;
- Be able to complete the study according to the requirements of the test plan;
- Male subjects aged 18-65 years (included);
- The subject should weigh at least 50kg. Body mass index (BMI) = weight (kg)/ height2(m2), BMI in the range of 19 to 26 (included);
- Health status: no mental abnormality, no medical history of abnormal cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolism;
Key exclusion criteria (19 listed)
- Have a history of neuropsychiatric system, respiratory system, cardiovascular system, digestive system, hemolymph system, liver and kidney insufficiency, endocrine system, skeletal and musculoskeletal system disease or other diseases, and the investigators judge that this history may affect drug metabolism or safety;
- Known allergic to Ramucirumab or its excipients; Known history of allergic diseases or allergic constitution;
- History of hypertension or abnormal blood pressure at screening/baseline measurement (systolic blood pressure (SBP) > 140 mmHg, and/or diastolic blood pressure (DBP) >90 mmHg, confirmed by one repeat measurement on the same day);
- A history of clinically significant albuminuria (urine routine examination, albuminuria 2+ and above) or albuminuria as assessed by the investigator;
- Had received treatment of Ramucirumab or VEGFR2 receptor antagonist, or other antibody or protein drugs that target VEGFR2 receptor;
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 |
|---|---|---|
| Ramucirumab InjectionRamucirumab injection biosimilar products manufactured by Chia Tai Tianqing Pharmaceutical, | Drug | Ramucirumab injection |
| Ramucirumab Injection [Cyramza]Ramucirumab Injection is a humanized monoclonal antibody based on the human immunoglobulin G1(IgG1) skeleton sequence, developed by Eli Lilly Co., the bran name is Cyramza. Ramucirumab is a vascular endothelial growth factor receptor 2 (VEGFR2) antagonist that specifically binds to VEGF receptor 2 and blocks VEGFR ligand, VEGF-A, VEGF-C, and VEGF-D binding to the receptor. As a result, Ramucirumab inhibits ligand-stimulated VEGF receptor 2 activation, thereby inhibiting ligand-induced proliferation, and human endothelial cell migration. Ramucirumab inhibits angiogenesis, thereby blocking the tumor's blood vessel supply. | Drug | Cyramza |
Primary outcome
Area under drug concentration - time curve (AUC0-t)
Time frame: Within 60 minutes before administration to 1680 hours after administration.
Area under the curve from zero to the lowest detectable blood drug concentration.
6 secondary outcomes
Area under drug concentration - time curve (AUC0-∞)
Time frame: Within 60 minutes before administration to 1680 hours after administration.
Peak concentration (Cmax)
Time frame: Within 60 minutes before administration to 1680 hours after administration.
Peak concentration time (Tmax)
Time frame: Within 60 minutes before administration to 1680 hours after administration.
Clearance rate (CL)
Time frame: Within 60 minutes before administration to 1680 hours after administration.
Half-life (T1/2)
Time frame: Within 60 minutes before administration to 1680 hours after administration.
Apparent volume of distribution (Vd)
Time frame: Within 60 minutes before administration to 1680 hours after administration.
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 5 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ramucirumab Injection and Ramucirumab Injection [Cyramza] in people with Gastric Cancer and Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site 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 7 inclusion and 19 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 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Area under drug concentration - time curve (AUC0-t) (time frame: Within 60 minutes before administration to 1680 hours after administration.). 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 5 Apr 2023.