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PK and Safety of SCT510

Healthy Clinical Trial

Official title:
A Randomized, Double-blind, Parallel-controlled Phase I Clinical Study Comparing the Pharmacokinetics, Safety and Immunogenicity of SCT510 With Bevacizumab (Avastin®) in Chinese Healthy Males

Clinical Trial Summary

This is a randomized, double-blind, parallel-controlled phase I clinical study comparing the pharmacokinetics, safety and immunogenicity of SCT510 with bevacizumab (Avastin®) in Chinese healthy males.

Clinical Trial Description

Eighty-four subjects randomly (1:1) received a 3 mg/kg dose of SCT510 or bevacizumab infusion for 90 min and followed up for 99 days. The screening period of this study is 14 days. Subjects will be admitted to the research center on day-1 and will be allowed to leave the research center with relevant observation and evaluation on day 5 (96 hours) after the completion of the administration. Subjects were asked to return for 10 follow-up visits respectively according to this research protocol, on the day 8, day 15, day 22, day 29, day 43, day 57, day 64, day 71, day 85 and day 99. All subjects in each group will be blinded after blood/urine collection and safety evaluation. Blood samples will be tested by a validated LC/MS method for pharmacokinetic study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05113511
Study type Interventional
Source First Affiliated Hospital of Zhejiang University
Contact
Status Completed
Phase Phase 1
Start date May 9, 2018
Completion date July 26, 2021
View Details
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