Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers

Study Overview
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Brief Summary
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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®.

Official Title
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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

Conditions
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Metastatic Breast Cancer, Metastatic Gastric Cancer

Intervention / Treatment
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* Drug: Trastuzumab for injection
* Drug: Herceptin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trastuzumab for injection<br>4mg/kg, Single dose for intravenous infusion | Drug: Trastuzumab for injection<br>* 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.<br>|
| Active Comparator: Herceptin<br>4mg/kg, Single dose for intravenous infusion | Drug: Herceptin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under drug concentration - time curve (AUC0-t) | 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-∞) | The area under the curve extrapolating from time zero to infinity | Within 30 minutes before administration to 1344 hours after administration | 
| Peak concentration (Cmax) | Peak maximum plasma drug concentration | Within 30 minutes before administration to 1344 hours after administration | 
| Time to reach maximum plasma (Tmax) | Time to reach maximum plasma concentration after dosing | Within 30 minutes before administration to 1344 hours after administration | 
| Clearance (CL) | Percentage of the body that eliminates organ-scavenging drugs | Within 30 minutes before administration to 1344 hours after administration | 
| half-life (T1/2) | 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) | Apparent volume of distribution after administration | Within 30 minutes before administration to 1344 hours after administration |