Status:
COMPLETED
Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-40 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2021
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04820439
Start Date
October 13 2020
End Date
March 13 2021
Last Update
March 29 2021
Active Locations (1)
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1
Phase I Clinical Research Center
Qingdao, Shandong, China, 266003