drugset / Trial / NCT05113511
PK and Safety of SCT510
Phase 1
Completed
84 enrolled
First Affiliated Hospital of Zhejiang University
Sinocelltech Ltd. · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2018-05-09
- Primary completion
- 2018-11-28
- Completion
- 2021-07-26
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | SCT510 | Monoclonal antibody | 3 mg/kg | Intravenous |
Indications
No indication recorded.