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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2021

Interventions

  • Drug: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)
    • A single intravenous infusion of HS627 420mg
  • Drug: Perjeta ®
    • A single intravenous infusion of Perjeta ®420mg

Arms, Groups and Cohorts

  • Experimental: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)
  • Active Comparator: Perjeta ®

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • The total clearance(CL)
    • Time Frame: 150 days
    • Evaluation of the total clearance(CL)
  • elimination half-life time(T1/2)
    • Time Frame: 150 days
    • Evaluation of elimination half-life time(T1/2)

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The Affiliated Hospital of Qingdao University
  • Provider of Information About this Clinical Study
    • Sponsor

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