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

NCT04820439 | Completed Phase 1

• 1 other identifier: HS627-BE
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• The total clearance(CL)

  150 days

• elimination half-life time(T1/2)

  150 days

Study Arms (2)

recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)

EXPERIMENTAL

Drug: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)

Perjeta ®

ACTIVE COMPARATOR

Drug: Perjeta ®

Interventions

recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) DRUG

A single intravenous infusion of HS627 420mg

recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)

Perjeta ® DRUG

A single intravenous infusion of Perjeta ®420mg

Perjeta ®

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Interventions

pertuzumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: October 13, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 13, 2021
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

CN (1)