Evidence map›Paper›PMID 40232626›Full record

Trial reportAdvances in therapy2025

A Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of A140 Injection and Cetuximab (Erbitux

Jia Xu, Junyou Ge, Yaling Li, Shulin Liu, Sicong Li, Jing Si, Juncheng Liu, Xiaoxue Zhu, Yanhua Ding

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

Trial report in Advances in therapy, 2025. 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

9 authors.

Jia XuPhase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, Jilin, China.
Junyou GeSichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Chengdu, Sichuan, China.
Yaling LiSichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Chengdu, Sichuan, China.
Shulin LiuSichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Chengdu, Sichuan, China.
Sicong LiSichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Chengdu, Sichuan, China.
Jing SiSichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Chengdu, Sichuan, China.
Juncheng LiuSichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Chengdu, Sichuan, China.
Xiaoxue Zhu *Phase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, Jilin, China. zhuxiaoxue@jlu.edu.cn.
Yanhua Ding *Phase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, Jilin, China. dingyanh@jlu.edu.cn.ORCID http://orcid.org/0000-0003-2320-4404

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study aimed to compare the pharmacokinetic (PK) profiles, safety, and immunogenicity of the proposed A140 with those of cetuximab (Erbitux

methodsWe conducted a randomized, single-dose, double-blind, parallel-controlled phase I study in which 82 healthy subjects were randomized equally into the A140 group and the cetuximab group. Both the test and comparator drug were administered as a single intravenous (IV) dose of 250 mg/m

resultsThe results showed that the 90% CI of the GMR for PK parameters (AUC

conclusionA140 demonstrated similar PK to cetuximab and comparable safety and immunogenicity in healthy Chinese male subjects.

trial registrationCTR20182229 ( https://www.chinadrugtrials.org.cn/ ).

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCetuximabAdultArea Under CurveChinaDouble-Blind MethodEast Asian PeopleHealthy VolunteersHumansMaleMiddle AgedTherapeutic EquivalencyYoung AdultAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCetuximabA140CetuximabImmunogenicityPharmacokineticsSafety

Identifiers

PMID40232626

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.