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

Qingdao University

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627); Drug: Perjeta ®

Study type: Interventional

Funder types: Other

Identifiers

NCT04820439

HS627-BE

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

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

Experimental group

Treatment:

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

Perjeta ®

Active Comparator group

Treatment:

Drug: Perjeta ®