Evidence map›Paper›PMID 39546188›Full record

Trial reportClinical drug investigation2024

A Phase I Clinical Trial to Evaluate the Bioequivalence of an Adalimumab Biosimilar Adalimumab-WIBP and Humira

Shengling Hu, Yang Liu, Lu Yang, Yunkai Yang, Feiguang Long, Hongying Bao, Huijun Zhang, Xin Yue, Jiayou Zhang, Zejun Wang and 6 more

Abstract readClinical Trial, Phase IEquivalence TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 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
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.

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

16 authors.

Shengling Hu *Phase I Clinical Trial Laboratory, Wuhan Jinyintan Hospital, Tongji Medical College of Huazhong University of Science and Technology; Hubei Clinical Research Center for Infectious Diseases, Wuhan Research Center for Communicable Disease Diagnosis and Treatment, Chinese Academy of Medical Sciences, Joint Laboratory of Infectious Diseases and Health, Wuhan Institute of Virology and Wuhan Jinyintan Hospital, Chinese Academy of Sciences, Wuhan, 430023, China.
Yang Liu *Clinical Medicine Center, China National Biotec Group Company Limited, Beijing, 100029, China.
Lu Yang *Antibody Research Department, Wuhan Institute of Biological Products Co. Ltd., Wuhan, 430207, China.
Yunkai YangClinical Medicine Center, China National Biotec Group Company Limited, Beijing, 100029, China.
Feiguang LongClinical Medicine Center, China National Biotec Group Company Limited, Beijing, 100029, China.
Hongying BaoClinical Medicine Center, China National Biotec Group Company Limited, Beijing, 100029, China.
Huijun ZhangClinical Medicine Center, China National Biotec Group Company Limited, Beijing, 100029, China.
Xin YueAntibody Research Department, Wuhan Institute of Biological Products Co. Ltd., Wuhan, 430207, China.
Jiayou ZhangAntibody Research Department, Wuhan Institute of Biological Products Co. Ltd., Wuhan, 430207, China.
Zejun WangAntibody Research Department, Wuhan Institute of Biological Products Co. Ltd., Wuhan, 430207, China.
Chaolin HuangPhase I Clinical Trial Laboratory, Wuhan Jinyintan Hospital, Tongji Medical College of Huazhong University of Science and Technology; Hubei Clinical Research Center for Infectious Diseases, Wuhan Research Center for Communicable Disease Diagnosis and Treatment, Chinese Academy of Medical Sciences, Joint Laboratory of Infectious Diseases and Health, Wuhan Institute of Virology and Wuhan Jinyintan Hospital, Chinese Academy of Sciences, Wuhan, 430023, China.
Jingli WangPhase I Clinical Trial Laboratory, Wuhan Jinyintan Hospital, Tongji Medical College of Huazhong University of Science and Technology; Hubei Clinical Research Center for Infectious Diseases, Wuhan Research Center for Communicable Disease Diagnosis and Treatment, Chinese Academy of Medical Sciences, Joint Laboratory of Infectious Diseases and Health, Wuhan Institute of Virology and Wuhan Jinyintan Hospital, Chinese Academy of Sciences, Wuhan, 430023, China.
Liu XiaPhase I Clinical Trial Laboratory, Wuhan Jinyintan Hospital, Tongji Medical College of Huazhong University of Science and Technology; Hubei Clinical Research Center for Infectious Diseases, Wuhan Research Center for Communicable Disease Diagnosis and Treatment, Chinese Academy of Medical Sciences, Joint Laboratory of Infectious Diseases and Health, Wuhan Institute of Virology and Wuhan Jinyintan Hospital, Chinese Academy of Sciences, Wuhan, 430023, China.
Yongbing PanAntibody Research Department, Wuhan Institute of Biological Products Co. Ltd., Wuhan, 430207, China. yongbingpan@163.com.
Yuntao ZhangClinical Medicine Center, China National Biotec Group Company Limited, Beijing, 100029, China. zhangyuntao@sinopharm.com.
Fengyun GongPhase I Clinical Trial Laboratory, Wuhan Jinyintan Hospital, Tongji Medical College of Huazhong University of Science and Technology; Hubei Clinical Research Center for Infectious Diseases, Wuhan Research Center for Communicable Disease Diagnosis and Treatment, Chinese Academy of Medical Sciences, Joint Laboratory of Infectious Diseases and Health, Wuhan Institute of Virology and Wuhan Jinyintan Hospital, Chinese Academy of Sciences, Wuhan, 430023, China. 2020jy0008@hust.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesThe high costs associated with biological agents often limit accessibility for many patients, whereas biosimilars allow the wider application of biological treatment. The objectives of this phase I clinical trial were to compare the pharmacokinetics, immunogenicity, and safety profiles of the biosimilar adalimumab-WIBP and the reference product Humira

methodsIn this randomized, double-blind, parallel-group bioequivalence study, 164 healthy male Chinese participants were selected and randomly divided into two groups on a 1:1 ratio. The subjects were administered a single 40 mg subcutaneous dose of either adalimumab-WIBP or Humira

resultsThe pharmacokinetic results demonstrated similar serum concentration-time curves in both groups. There were no significant differences in safety and no differences in immunogenicity profiles between the two groups. The bioequivalence was confirmed: the 90% confidence interval for the geometric mean ratio of the main pharmacokinetic parameters was within the range of 80-125%.

conclusionThe trial indicated the bioequivalence between adalimumab-WIBP and the reference product Humira

Indexed as

AdalimumabBiosimilar PharmaceuticalsTherapeutic EquivalencyAdultDouble-Blind MethodHealthy VolunteersHumansInjections, SubcutaneousMaleYoung AdultAdalimumabBiosimilar Pharmaceuticals

Identifiers

PMID39546188

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.