Evidence map›Paper›PMID 41579173›Full record

Trial reportNaunyn-Schmiedeberg's archives of pharmacology2026

Phase I randomized double-blind parallel-group study: pharmacokinetics, safety, and immunogenicity of pertuzumab biosimilar SYSA1901 in healthy Chinese males.

Yucai Xu, Xueyuan Zhang, Hailin Zhang, Jingjing Yang, Qian Zhang, Huiling Qin, Qin Zhang, Wei Zhang, Renpeng Zhou, Wei Hu and 1 more

Abstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Publisher
In one paragraph

Trial report in Naunyn-Schmiedeberg's archives of pharmacology, 2026. 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
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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

11 authors.

Yucai Xu *Department of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, 230601, China.
Xueyuan Zhang *CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., Shijiazhuang, 050000, Hebei Province, China.
Hailin Zhang *Department of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, 230601, China.
Jingjing YangDepartment of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, 230601, China.
Qian ZhangDepartment of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, 230601, China.
Huiling QinDepartment of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, 230601, China.
Qin ZhangDepartment of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, 230601, China.
Wei ZhangDepartment of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, 230601, China.
Renpeng ZhouDepartment of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, 230601, China. zhourenpeng@ahmu.edu.cn.
Wei HuDepartment of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, 230601, China. huwei@ahmuedu.cn.
Chunlei LiCSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., Shijiazhuang, 050000, Hebei Province, China. lchunlei@cspc.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pertuzumab, administered as an injection, is an antagonist of human epidermal growth factor receptor 2 (HER2). This study sought to compare the pharmacokinetic (PK) profiles, safety, and immunogenicity between pertuzumab biosimilar SYSA1901 injection and the reference product (Perjeta®) in healthy males. In this single-center, randomized, double-blind, parallel-group, single-dose trial, 88 male subjects were enrolled and randomized into two groups, each receiving a single 420 mg (14 mL) intravenous infusion of SYSA1901 or pertuzumab (Perjeta®), respectively. Primary endpoint: serum concentration-time curve area from 0 to infinity (AUC

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiosimilar PharmaceuticalsAdolescentAdultArea Under CurveDouble-Blind MethodEast Asian PeopleErb-b2 Receptor Tyrosine KinasesHumansInfusions, IntravenousMaleTherapeutic EquivalencyYoung AdultAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiosimilar PharmaceuticalsErb-b2 Receptor Tyrosine KinasespertuzumabBiosimilarImmunogenicityPertuzumabPharmacokineticSYSA1901

Identifiers

PMID41579173

What Socratic holds

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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 Socratic graph.