Evidence map›Paper›PMID 39317850›Full record

Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2024

Pharmacokinetics, Safety, and Immunogenicity of a Biosimilar of Nivolumab (LY01015): A Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Trial in Healthy Chinese Male Subjects.

Wei Wang, Shengnan Zhang, Changlin Dou, Baihui Hu, Hongtao Song, Fan Qi, Yanyan Zhao, Xiaojing Li, Ming Zhou, Jinlian Xie and 7 more

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

Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 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

17 authors.

Wei Wang *Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Shengnan Zhang *Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Changlin DouShandong Boan Biotechnology Co. Ltd, Luye Life Sciences Group, Beijing, China.
Baihui HuClinical Research Center of Luye Pharma Group Ltd, Luye Life Sciences Group, Beijing, China.
Hongtao SongClinical Research Center of Luye Pharma Group Ltd, Luye Life Sciences Group, Beijing, China.
Fan QiShandong Boan Biotechnology Co. Ltd, Luye Life Sciences Group, Beijing, China.
Yanyan ZhaoShandong Boan Biotechnology Co. Ltd, Luye Life Sciences Group, Beijing, China.
Xiaojing LiShandong Boan Biotechnology Co. Ltd, Luye Life Sciences Group, Beijing, China.
Ming ZhouShandong Boan Biotechnology Co. Ltd, Luye Life Sciences Group, Beijing, China.
Jinlian XieCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Kunhong DengCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Qian WuCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Ling YeCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Chang CuiCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Li LiuCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Jie Huang *Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Guoping Yang *Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China. ygp9880@126.com.ORCID http://orcid.org/0000-0001-5930-586X

Funding

Natural Science Foundation of Hunan Province 2023JJ60513
6 · The paper itself

Abstract

backgroundNivolumab (Opdivo

objectivesThis phase I study aimed to establish the pharmacokinetic equivalence between LY01015 and the original investigational nivolumab (Opdivo PATIENTS AND

methodsA randomized, double-blind, parallel-controlled, phase I trial was conducted with 176 healthy male adults receiving a single intravenous infusion of LY01015 or nivolumab at 0.3 mg/kg. Pharmacokinetics, safety, and immunogenicity were evaluated over a 99-day period. The primary pharmacokinetics endpoint was AUC

resultsThis study is the first to report on the pharmacokinetics, safety, and immunogenicity of Opdivo

conclusionsLY01015 demonstrated highly similar pharmacokinetics to nivolumab in healthy Chinese male subjects. Both drugs exhibited comparable safety and immunogenicity profiles.

trial registrationThis trial is registered at the Chinese Clinical Trial Registry website ( https://www.chictr.org.cn/ #ChiCTR2200064771).

Indexed as

Biosimilar PharmaceuticalsNivolumabTherapeutic EquivalencyAdultArea Under CurveDouble-Blind MethodEast Asian PeopleHealthy VolunteersHumansMaleYoung AdultBiosimilar PharmaceuticalsNivolumab

Identifiers

PMID39317850

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.