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| Name | Class |
|---|---|
| Sinocelltech Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCT510 | Experimental | SCT510 |
|
| bevacizumab | Active Comparator | bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT510 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 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 | 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 ] |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to Cmax | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41495391 | Derived | Hong Q, Jiao Y, Li D, Ma H, Wu K, Xie L. Population Pharmacokinetics of SCT510 (a Bevacizumab Biosimilar) and Avastin(R) in Healthy Subjects and Patients with Non-squamous Non-small Cell Lung Cancer. Clin Drug Investig. 2026 Feb;46(2):143-157. doi: 10.1007/s40261-025-01518-8. Epub 2026 Jan 6. | |
| 37247166 | Derived |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab | Drug | 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. |
|
number of participants with anti-drug antibody positive at post-dose
| up to 99 days |
| Number of Participants With neutralizing antibody Positive | number of participants with neutralizing antibody positive at post-dose | up to 99 days |
| Wu J, Wu G, Xie L, Lv D, Xu C, Zhou H, Wu L, Zhang J, Shentu J. A Randomized, Double-Blind, Parallel-Controlled Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of SCT510 to Bevacizumab (Avastin(R)) in Healthy Chinese Males. Drugs R D. 2023 Jun;23(2):175-183. doi: 10.1007/s40268-023-00424-8. Epub 2023 May 29. |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |