PMID- 37247166 OWN - NLM STAT- MEDLINE DCOM- 20230630 LR - 20230701 IS - 1179-6901 (Electronic) IS - 1174-5886 (Print) IS - 1174-5886 (Linking) VI - 23 IP - 2 DP - 2023 Jun TI - 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. PG - 175-183 LID - 10.1007/s40268-023-00424-8 [doi] AB - BACKGROUND: SCT510 is a recombinant humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF), which is intended as a candidate biosimilar of bevacizumab that is approved for various metastatic cancers.Please confirm change in wording to match definition for VEGF belowYes. OBJECTIVE: This study aimed to compare the pharmacokinetics profiles, safety, and immunogenicity of SCT510 to bevacizumab (Avastin((R))) in healthy Chinese males. METHODS: This was a single-center, double-blind, parallel-group phase I study. A total of 84 participants were randomly assigned (1:1) to receive a single 3 mg/kg infusion of either SCT510 or bevacizumab and followed up for 99 days. Primary endpoints were area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC(0-infinity)), area under the serum concentration-time curve from time 0 to last quantifiable concentration (AUC(0-t)), and the maximum observed concentration (C(max)). Secondary endpoints included safety and immunogenicity.Kindly check and confirm the edit made in the article title.Yes. RESULTS: A total of 82 subjects completed the study. Geometric means ratios (GMR) for AUC(0-infinity), AUC(0-t), and C(max) were 0.88, 0.89, and 0.97, respectively, for SCT510 versus bevacizumab (USA). The 90% confidence intervals for GMRs of AUC(0-infinity), AUC(0-t), and C(max) were all within the prespecified criteria (80-125%). No adverse events (AEs) led to study termination, and no serious adverse events (SAEs) were reported. None of the anti-drug antibodies (ADAs) identified were found to be neutralizing antibodies (NAbs), and only one subject from the SCT510 group tested positive for the ADA at the day 99 visit. CONCLUSION: This study demonstrated that the pharmacokinetics, safety, and immunogenicity of SCT510 were equivalent to bevacizumab (Avastin((R))). As a proposed biosimilar drug to bevacizumab, SCT510 was well tolerated in healthy Chinese males. CLINICAL TRIALS REGISTRATION: NCT05113511. CI - (c) 2023. The Author(s). FAU - Wu, Jing AU - Wu J AD - Research Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. AD - Zhejiang University School of Medicine, Hangzhou, China. FAU - Wu, Guolan AU - Wu G AD - Research Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. AD - Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. FAU - Xie, Liangzhi AU - Xie L AD - Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing, China. AD - Sinocelltech Ltd., No. 31 Kechuang 7th Street, BDA, Beijing, China. FAU - Lv, Duo AU - Lv D AD - Research Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. AD - Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. FAU - Xu, Chang AU - Xu C AD - Research Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. AD - Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. FAU - Zhou, Huili AU - Zhou H AD - Research Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. AD - Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. FAU - Wu, Lihua AU - Wu L AD - Research Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. FAU - Zhang, Jingjing AU - Zhang J AD - Research Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. AD - Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. FAU - Shentu, Jianzhong AU - Shentu J AUID- ORCID: 0000-0002-7293-9768 AD - Research Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. stjz@zju.edu.cn. AD - Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. stjz@zju.edu.cn. LA - eng SI - ClinicalTrials.gov/NCT05113511 GR - 2018ZX09736002/National Major Scientific and Technological Special Project for "Significant New Drugs Development "/ PT - Clinical Trial, Phase I PT - Journal Article PT - Randomized Controlled Trial DEP - 20230529 PL - New Zealand TA - Drugs R D JT - Drugs in R&D JID - 100883647 RN - 2S9ZZM9Q9V (Bevacizumab) RN - 0 (Biosimilar Pharmaceuticals) SB - IM MH - Humans MH - Male MH - Area Under Curve MH - *Bevacizumab/pharmacokinetics MH - *Biosimilar Pharmaceuticals MH - Double-Blind Method MH - East Asian People MH - Healthy Volunteers MH - Therapeutic Equivalency PMC - PMC10293153 COIS- Dr. Liangzhi Xie is employee of Sinocelltech Ltd. and has ownership or potential stock option interests in the company. All authors declare no other conflicts of interest. EDAT- 2023/05/29 13:04 MHDA- 2023/06/28 06:42 PMCR- 2023/05/29 CRDT- 2023/05/29 11:12 PHST- 2023/04/23 00:00 [accepted] PHST- 2023/06/28 06:42 [medline] PHST- 2023/05/29 13:04 [pubmed] PHST- 2023/05/29 11:12 [entrez] PHST- 2023/05/29 00:00 [pmc-release] AID - 10.1007/s40268-023-00424-8 [pii] AID - 424 [pii] AID - 10.1007/s40268-023-00424-8 [doi] PST - ppublish SO - Drugs R D. 2023 Jun;23(2):175-183. doi: 10.1007/s40268-023-00424-8. Epub 2023 May 29.