NCT05113511

PK and Safety of SCT510

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SCT510	Subjects received a single intravenous infusion (3 mg/kg) of SCT510 for 90 minutes , and the volume of administration was calculated based on the subject's weight.
DRUG	Bevacizumab	Subjects received a single intravenous infusion (3 mg/kg) of bevacizumab for 90 minutes , and the volume of administration was calculated based on the subject's weight.

Timeline

• Start date: 2018-05-09
• Primary completion: 2018-11-28
• Completion: 2021-07-26
• First posted: 2021-11-09
• Last updated: 2021-11-09

Locations

1 site across 1 country: China