Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection

Study Overview
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Brief Summary
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This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.

Official Title
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Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection (HS627) and Perjeta ® in Healthy Male Subjects: a Randomized, Double-blind, Parallelity-controlled Study

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)
* Drug: Perjeta ®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male aged 18-40. The body mass index is in the range of 19-26 kg/m2 (including thecritical value). The weight is 50 kg-80kg. The subjects have no family planning within 3 months and could select contraceptive method The subjects who have signed the informed consent and are able to complete the experiment according to the trial protocol. Echocardiography showed left ventricular ejection fraction (LVEF) > 50% ,which two weeks before administration of experimental drug. Exclusion Criteria: The subjects with a history of malignant tumor. The subjects who has received any live vaccine within 6 months prior to signing the informed consent. The subjects who has upper respiratory tract infection or other acute infections within the previous 2 weeks of screening. The subjects who had undergone surgery within 2 months prior to signing the informed consent. Anti-drug antibody (ADA) detection positive. Previous treatment with any antibody targeting the HER2 receptor or Those who have used monoclonal antibodies within 6 months prior to signing the informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)<br> | Drug: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)<br>* A single intravenous infusion of HS627 420mg<br>|
| Active Comparator: Perjeta ®<br> | Drug: Perjeta ®<br>* A single intravenous infusion of Perjeta ®420mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC)0-∞ | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ | 150 days | 
| Area under the plasma concentration versus time curve (AUC)0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | 150 days | 
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 150 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total clearance(CL) | Evaluation of the total clearance(CL) | 150 days | 
| elimination half-life time(T1/2) | Evaluation of elimination half-life time(T1/2) | 150 days |