- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05765357
Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers
March 1, 2023 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase I Clinical Study of Randomized, Double-blind, Single-dose, Parallel Comparison of Trastuzumab for Injection and Herceptin® in Healthy Male Volunteers on Pharmacokinetics and Safety
Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells.
A randomized, double-blind, single-dose, parallel phase I study comparing trastuzumab for injection with Herceptin ® in healthy male volunteers was conducted to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of Trastuzumab for injection and Herceptin®.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
89
Phase
- 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
-
-
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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Fully understand the purpose of the trial, and have a basic understanding of the pharmacological effects and possible adverse reactions of the drug under study; Voluntary written informed consent in accordance with the Helsinki Declaration;
- Healthy male subjects aged ≥ 18 years and ≤ 65 years;
- Body weight ≥ 50 kg ≤ 90 kg, body mass index ≥ 18 ≤ 28kg/m2;
- The system examination indicators were within the normal range, or the examination results were abnormal but the researchers judged that there was no clinical significance;
- Subjects agree to use reliable contraceptive methods for both themselves and their partners during the study period and for 6 months after the study drug infusion.
Exclusion Criteria:
- History of hypertension or abnormal blood pressure at screening/baseline measurement;
- A history of albuminuria or albuminuria as assessed by the investigator as clinically significant;
- Received any antibody or protein targeting Vascular Endothelial Cell Growth Factor (VEGF) or VEGF receptors in the previous 1 year;
- Study the use of any biological product or live virus vaccine within 3 months prior to drug infusion, or the use of any monoclonal antibody within 12 months;
- Have an inherited tendency to bleed or have coagulation dysfunction, or have a history of thrombosis or bleeding;
- History of digestive tract perforation or digestive tract fistula;
- Unhealed wound ulcers or fractures, or major surgery within 2 months prior to randomization or expected to be performed during the study period or within 2 months after study completion;
- Use of a prescription or over-the-counter drug or nutritional supplement within the 5 half-life of the drug or nutritional supplement or within 2 weeks prior to the study drug use;
- Positive virology test;
- Known allergy to trastuzumab;
- Known history of allergic diseases or allergic constitution;
- Study the history of blood donation 3 months before drug infusion;
- Received any other investigational drug therapy or participated in another interventional clinical trial within 2 months prior to screening
- A history of alcohol or drug abuse in the 12 months prior to screening;
- A history of mental illness;
- Subjects whose spouses plan to become pregnant;
- The study cannot be completed according to protocol requirements during the study period;
- 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 |
Intervention / Treatment |
---|---|
Experimental: Trastuzumab for injection
4mg/kg, Single dose for intravenous infusion
|
Trastuzumab for injection manufactured by Chia Tai Tianqing.
Trastuzumab is a humanized IGG1-class monoclonal antibody produced by CHO cells.
Its mechanism of action is to prevent the attachment of human epidermal growth factor to Her2 by attaching itself to Her2, thus blocking the growth of cancer cells.
In addition, Trastuzumab can also stimulate the body's own immune cells to destroy cancer cells.
|
Active Comparator: Herceptin
4mg/kg, Single dose for intravenous infusion
|
Herceptin is the brand name of Trastuzumab for injection manufactured by Roche.
Trastuzumab is a humanized IGG1-class monoclonal antibody produced by CHO cells.
Its mechanism of action is to prevent the attachment of human epidermal growth factor to Her2 by attaching itself to Her2, thus blocking the growth of cancer cells.
In addition, Trastuzumab can also stimulate the body's own immune cells to destroy cancer cells.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under drug concentration - time curve (AUC0-t)
Time Frame: Within 30 minutes before administration to 1344 hours after administration
|
Area under the curve from time zero to the lowest detectable blood drug concentration
|
Within 30 minutes before administration to 1344 hours after administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under drug concentration - time curve (AUC0-∞)
Time Frame: Within 30 minutes before administration to 1344 hours after administration
|
The area under the curve extrapolating from time zero to infinity
|
Within 30 minutes before administration to 1344 hours after administration
|
Peak concentration (Cmax)
Time Frame: Within 30 minutes before administration to 1344 hours after administration
|
Peak maximum plasma drug concentration
|
Within 30 minutes before administration to 1344 hours after administration
|
Time to reach maximum plasma (Tmax)
Time Frame: Within 30 minutes before administration to 1344 hours after administration
|
Time to reach maximum plasma concentration after dosing
|
Within 30 minutes before administration to 1344 hours after administration
|
Clearance (CL)
Time Frame: Within 30 minutes before administration to 1344 hours after administration
|
Percentage of the body that eliminates organ-scavenging drugs
|
Within 30 minutes before administration to 1344 hours after administration
|
half-life (T1/2)
Time Frame: Within 30 minutes before administration to 1344 hours after administration
|
The time it takes for serum drug concentrations to drop by half
|
Within 30 minutes before administration to 1344 hours after administration
|
Apparent volume of distribution (Vd/F)
Time Frame: Within 30 minutes before administration to 1344 hours after administration
|
Apparent volume of distribution after administration
|
Within 30 minutes before administration to 1344 hours after administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
July 16, 2017
Primary Completion (Actual)
October 27, 2017
Study Completion (Actual)
October 27, 2017
Study Registration Dates
First Submitted
March 1, 2023
First Submitted That Met QC Criteria
March 1, 2023
First Posted (Actual)
March 13, 2023
Study Record Updates
Last Update Posted (Actual)
March 13, 2023
Last Update Submitted That Met QC Criteria
March 1, 2023
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZDTQ-2017-QTZDK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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