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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04820439
• Other study ID #: HS627-BE
• Status: Completed
• Phase: Phase 1
• Start date: October 13, 2020
• Est. completion date: March 13, 2021

Study information

• Verified date: March 2021
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 13, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
China	Phase I Clinical Research Center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC)0-8	Evaluation of Area under the plasma concentration versus time curve (AUC)0-8	150 days
Primary	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
Primary	Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	150 days
Secondary	The total clearance(CL)	Evaluation of the total clearance(CL)	150 days
Secondary	elimination half-life time(T1/2)	Evaluation of elimination half-life time(T1/2)	150 days