Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection
NCT ID: NCT04820439
Last Updated: 2021-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
88 participants
INTERVENTIONAL
2020-10-13
2021-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)
recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)
A single intravenous infusion of HS627 420mg
Perjeta ®
Perjeta ®
A single intravenous infusion of Perjeta ®420mg
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
40 Years
MALE
Yes
Sponsors
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The Affiliated Hospital of Qingdao University
OTHER
Responsible Party
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Locations
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Phase I Clinical Research Center
Qingdao, Shandong, China
Countries
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Other Identifiers
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HS627-BE
Identifier Type: -
Identifier Source: org_study_id
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