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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
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.
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.
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
AUC0-inf
area under the concentration-time curve from time zero (pre-dose) extrapolate area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336, 504,672, 1,008, 1,344, 1,512, 1,680, and 2,016 hours after SOI ]
AUC0-last
area under the concentration-time curve from time zero (pre-dose) extrapolated to last quantifiable concentration (AUC0-t)
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336, 504,672, 1,008, 1,344, 1,512, 1,680, and 2,016 hours after SOI ]
Cmax
Maximum Serum Concentration
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336, 504,672, 1,008, 1,344, 1,512, 1,680, and 2,016 hours after SOI ]
Tmax
Time to Cmax
Time frame: pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336, 504,672, 1,008, 1,344, 1,512, 1,680, and 2,016 hours after SOI ]
Number of Participants With Anti-Drug Antibody Positive
number of participants with anti-drug antibody positive at post-dose
Time frame: up to 99 days
Number of Participants With neutralizing antibody Positive
number of participants with neutralizing antibody positive at post-dose
Time frame: up to 99 days
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