Clinical Study to Compare the Pharmacokinetics and Safety of Ramucirumab Injection With Cyramza ® in Healthy Male Volunteers

March 24, 2023 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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®.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ramucirumab injection
8mg/kg, Single intravenous infusion
Drug: Ramucirumab Injection
Ramucirumab injection biosimilar products manufactured by Chia Tai Tianqing Pharmaceutical,
Active Comparator: Cyramza
8mg/kg, Single intravenous infusion
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within 60 minutes before administration to 1680 hours after administration.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under drug concentration - time curve (AUC0-∞)
Time Frame: Within 60 minutes before administration to 1680 hours after administration.
The area under the curve extrapolating from zero to infinity.
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 maximum plasma drug concentration
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.
Time to reach maximum plasma concentration after dosing
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.
Percentage of the organ-scavenging drugs that eliminated by the body
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.
The time it takes for serum drug concentrations to drop by half
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.
Apparent volume of distribution after administration
Within 60 minutes before administration to 1680 hours after administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 18, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZDTQ-2019-LMLDK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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