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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627); Drug: Perjeta ®

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • Phase I Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): March 13, 2021

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Mitosis Modulators; Antineoplastic Agents, Immunological; Antibodies; Antibodies, Monoclonal; Pertuzumab; Mitogens
• Other Study ID Numbers: HS627-BE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No