Evidence map›Paper›PMID 33682358›Full record

Trial reportPharmacology research & perspectives2021

Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double-blind, parallel-controlled, phase 1 study.

Hong Zhang, Min Wu, Jixuan Sun, Xiaoxue Zhu, Cuiyun Li, Yanhua Ding, Xiaodi Zhang, Katherine Chai, Xiaojiao Li

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pharmacology research & perspectives, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03357939 (A Phase 1 Randomized,Double-Blind and Parallel Controlled Single-dose Clinical Trial of Pharmacokinetics, Safety, Tolerability and Immunogenicity of HLX03 Compared With Humira® From China Source in Chinese Healthy Male Subjects), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 56% 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.

NCT03357939 phase1completednot on this map

A Phase 1 Randomized,Double-Blind and Parallel Controlled Single-dose Clinical Trial of Pharmacokinetics, Safety, Tolerability and Immunogenicity of HLX03 Compared With Humira® From China Source in Chinese Healthy Male Subjects

TypeinterventionalSponsorShanghai Henlius BiotechRan2017 to 2018Enrolled220ConditionsImmune System DisorderArmsHLX03, adalimumab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. 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 3 institutions in 1 country.

Hong ZhangPhase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.
Min WuPhase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.
Jixuan SunPhase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.
Xiaoxue ZhuPhase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.
Cuiyun LiPhase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.
Yanhua DingPhase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.
Xiaodi ZhangShanghai Henlius Biotech, Inc., Shanghai, China.
Katherine ChaiShanghai Henlius Biotech, Inc., Shanghai, China.
Xiaojiao LiPhase 1 Clinical Research Center, the First Hospital of Jilin University, Changchun, China.
First Hospital of Jilin University · CNJilin University · CNViva Biotech (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The primary objective of this randomized, double-blind, parallel-controlled study (from December 2016 to October 2018) was to evaluate pharmacokinetic (PK) equivalence of adalimumab biosimilar HLX03 and reference adalimumab in healthy volunteers, and to assess safety, and immunogenicity of HLX03. The primary PK endpoints were maximum observed plasma concentration (C

Indexed as

AdalimumabAdolescentAdultArea Under CurveAsian PeopleBiosimilar PharmaceuticalsChinaDouble-Blind MethodHealthy VolunteersHumansMaleMiddle AgedTherapeutic EquivalencyTumor Necrosis Factor InhibitorsYoung AdultAdalimumabBiosimilar PharmaceuticalsTumor Necrosis Factor Inhibitorsadalimumabbioequivalencebiosimilarpharmacokinetics

Identifiers

PMID33682358
PMCPMC7937819
OpenAlexW3133489979

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.