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

Outcome

Met primary endpoint

paper The 90% confidence intervals for GMRs of AUC0-∞, AUC0-t, and Cmax were all within the prespecified criteria (80-125%). PMID 37247166 ↗

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.