Evidence map›Paper›PMID 38564097›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2024

A Phase I Clinical Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of GB221 Injection and Trastuzumab (Herceptin

Yu Zhu, Chen Li, Liming Chen, Haiyan Liu, Lun Ou, Tong Li, Xuan Wang, Tenghua Wang, Jingyuan Tian, Xintong Liang and 10 more

Abstract readClinical Trial, Phase IRandomized Controlled TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 94% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

20 authors at 6 institutions in 2 countries.

Yu Zhu *Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Chen Li *Phase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Liming Chen *Clinical Trial Institution Research Ward, Peking University People's Hospital, Beijing, China.
Haiyan LiuPhase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Lun OuBeijing United-Power Pharma Tech Co., Ltd., Beijing, China.
Tong LiDepartment of Clinical Development, Genor Biopharma Co., Ltd., Shanghai, China.
Xuan WangPhase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Tenghua WangPhase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Jingyuan TianScientific Research Center, Guangzhou Medical University, Guangzhou, China.
Xintong LiangPhase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Zhiqin HuPhase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Yaoxuan ZhanPhase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Shuangshuang XiaoPhase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Xiaole WangPhase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Yongmei LiPhase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Jin HePhase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China.
Qingshan ZhengThe Center for Drug Clinical Research of Shanghai University of TCM, Shanghai, China.
Haifeng SongState Key Laboratory of Proteomics, Beijing Proteome Research Center, National Center for Protein Sciences (Beijing), Beijing Institute of Lifeomics, Beijing, China. songhf@nic.bmi.ac.cn.
Xianbo LiPhase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China. 285641182@qq.com.
Yi FangPhase I Clinical Research Center, Key Laboratory of Biological Targeting Diagnosis, Therapy and Rehabilitation of Guangdong Higher Education Institutes, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510700, China. phaseistudy@163.com.ORCID http://orcid.org/0000-0002-3547-5829
Guangzhou Medical University · CNPeking University · CNBeijing Proteome Research Center · CNSecond Affiliated Hospital of Guangzhou Medical University · CNShanghai Genon Biological Products (China) · CNShanghai University · CN

Funding

Guangzhou Health Science and Technology Project 2021A031005the Major Project of National Science and Technology "Creation of Major New Drugs" 2020ZX09201026
6 · The paper itself

Abstract

BACKGROUND AND

objectiveGB221 is a recombinant humanized anti-HER2 monoclonal antibody. The purpose of this study was to evaluate the pharmacokinetic, safety, and immunogenicity of GB221 in healthy Chinese adults in comparison to trastuzumab (Herceptin

methodsIn this randomized, double-blind, parallel-group phase I clinical trial, 88 subjects were randomized 1:1 to receive a single intravenous infusion (90-100 min) of GB221 or trastuzumab (6 mg/kg). The primary pharmacokinetic parameters-maximum observed serum concentration (C

resultsThe GB221 group (n = 43) and the trastuzumab group (n = 44) showed similar pharmacokinetic characteristics. The geometric mean ratios (90% CI) of C

conclusionGB221 demonstrated similar pharmacokinetics to trastuzumab and comparable safety and immunogenicity in healthy Chinese adults.

Indexed as

Antineoplastic Agents, ImmunologicalArea Under CurveTherapeutic EquivalencyTrastuzumabAdultDouble-Blind MethodEast Asian PeopleErb-b2 Receptor Tyrosine KinasesFemaleHealthy VolunteersHumansInfusions, IntravenousMaleMiddle AgedYoung AdultAntineoplastic Agents, ImmunologicalErb-b2 Receptor Tyrosine KinasesTrastuzumab

Identifiers

PMID38564097
OpenAlexW4393398402

What OpenQuestion holds

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Registered trials

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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.