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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627); Drug: Perjeta ®

• Registration Number: NCT04820439
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-13
• Primary Completion: 2021-02-01
• Status Verified: 2021-03
• Study Completion: 2021-03-13
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Last Update Submitted: 2021-03-25
• Study First Posted: 2021-03-29
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)	recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)	-
Perjeta ®	Perjeta ®	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Phase I Clinical Research Center; 🇨🇳 Qingdao, Shandong, China