Evidence map›Paper›PMID 37247166›Full record

Trial reportDrugs in R&D2023

A Randomized, Double-Blind, Parallel-Controlled Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of SCT510 to Bevacizumab (Avastin

Jing Wu, Guolan Wu, Liangzhi Xie, Duo Lv, Chang Xu, Huili Zhou, Lihua Wu, Jingjing Zhang, Jianzhong Shentu

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Drugs in R&D, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05113511 (A Randomized, Double-blind, Parallel-controlled Phase I Clinical Study Comparing the Pharmacokinetics, Safety and Immunogenicity of SCT510 With Bevacizumab), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05113511 phase1completednot on this map

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

TypeinterventionalSponsorFirst Affiliated Hospital of Zhejiang UniversityRan2018 to 2021Enrolled84ConditionsHealthyArmsSCT510, Bevacizumab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Jing Wu *Research Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Guolan Wu *Research Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Liangzhi XieBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing, China.
Duo LvResearch Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Chang XuResearch Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Huili ZhouResearch Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Lihua WuResearch Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Jingjing ZhangResearch Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Jianzhong ShentuResearch Center of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. stjz@zju.edu.cn.ORCID http://orcid.org/0000-0002-7293-9768
First Affiliated Hospital Zhejiang University · CNSinocelltech Group (China) · CN

Funding

National Major Scientific and Technological Special Project for "Significant New Drugs Development " 2018ZX09736002
6 · The paper itself

Abstract

backgroundSCT510 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.

objectiveThis study aimed to compare the pharmacokinetics profiles, safety, and immunogenicity of SCT510 to bevacizumab (Avastin

methodsThis 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

resultsA total of 82 subjects completed the study. Geometric means ratios (GMR) for AUC

conclusionThis study demonstrated that the pharmacokinetics, safety, and immunogenicity of SCT510 were equivalent to bevacizumab (Avastin CLINICAL TRIALS REGISTRATION: NCT05113511.

Indexed as

BevacizumabBiosimilar PharmaceuticalsArea Under CurveDouble-Blind MethodEast Asian PeopleHealthy VolunteersHumansMaleTherapeutic EquivalencyBevacizumabBiosimilar Pharmaceuticals

Identifiers

PMID37247166
PMCPMC10293153
OpenAlexW4378640308

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.