Evidence map›Paper›PMID 28639118›Full record

Trial reportEuropean journal of clinical pharmacology2017

Pharmacokinetics and immunogenicity of T0001, a newly developed anti-TNFα fusion protein, in healthy volunteers.

Yitong Wang, Chang Liu, Shi Chen, Wei Wang, Lihou Dong, Qian Wang, Yan Wang, Libo Zhao, Yannan Zang, Zhenwei Xie and 5 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2017. 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
0.4field-weighted citation impact, top 34% 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.

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, 3 citations in OpenAlex.

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

15 authors at 6 institutions in 1 country.

Yitong WangDepartment of Pharmacy, Peking University People's Hospital, Beijing, 100044, China.
Chang LiuDepartment of Pharmacy, Peking University People's Hospital, Beijing, 100044, China.
Shi ChenDepartment of Rheumatology and Immunology, Peking University People's Hospital, Beijing, 100044, China.
Wei WangDepartment of Medicine, Shanghai Fudan-zhangjiang Bio-Pharmaceutical Co. Ltd, Shanghai, 201210, China.
Lihou DongDepartment of Pharmacology and Toxicology, Beijing Institute of Radiation Medicine, Beijing, 100850, China.
Qian WangDepartment of Pharmacy, Peking University People's Hospital, Beijing, 100044, China.
Yan WangDepartment of Pharmacy, Peking University People's Hospital, Beijing, 100044, China.
Libo ZhaoDepartment of Pharmacy, Beijing Children's Hospital, Capital Medical University, Beijing, 100045, China.
Yannan ZangDepartment of Pharmacy, Beijing Anding Hospital, Capital Medical University, Beijing, 100088, China.
Zhenwei XieDepartment of Scientific Research, Peking University People's Hospital, Beijing, 100044, China.
Yang LiuDepartment of Pharmacy, Peking University People's Hospital, Beijing, 100044, China.
Yanjun LiuAcademia Sinica, Shanghai Pharmaceuticals Holding Co. Ltd, Shanghai, 200020, China.
Haifeng SongDepartment of Pharmacology and Toxicology, Beijing Institute of Radiation Medicine, Beijing, 100850, China.
Zhanguo LiDepartment of Rheumatology and Immunology, Peking University People's Hospital, Beijing, 100044, China.
Yi FangDepartment of Pharmacy, Peking University People's Hospital, Beijing, 100044, China. phaseistudy@163.com.
Peking University People's Hospital · CNPeking University · CNBeijing Radiation Center · CNBeijing Children’s Hospital · CNCapital Medical University · CNShanghai Zhangjiang Laboratory · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeT0001 was the first mutant of recombinant fusion protein of human tumor necrosis factor receptor and Fc fragment (rhTNFR:Fc) based on etanercept on a global scale. This study was carried out to investigate the pharmacokinetics (PK) and immunogenicity of T0001 in healthy Chinese volunteers.

methodsThis study was randomized, with a single ascending dose, and the first-in-human clinical trial of T0001. Healthy Chinese volunteers (n = 56; male: female = 1:1) were randomly assigned to receive a single subcutaneous (sc) injection of 10, 20, 35, 50, 65 or 75 mg of T0001. Blood samples were collected at designated time points after sc injection to assess immunogenicity and pharmacokinetics of T0001.

resultsDuring the study, no serious adverse events were observed. T0001 was slowly absorbed with a median T

conclusionsT0001 was safe and well-tolerated at doses up to 75 mg. C

Indexed as

AdultAntibodiesFemaleHealthy VolunteersHumansImmunoglobulin Fc FragmentsMaleReceptors, Tumor Necrosis FactorRecombinant Fusion ProteinsTumor Necrosis Factor-alphaYoung AdultAntibodiesImmunoglobulin Fc FragmentsReceptors, Tumor Necrosis FactorRecombinant Fusion ProteinsT0001TNF protein, humanTumor Necrosis Factor-alphaClinical trialImmunogenicityPharmacokineticsT0001TNFα

Identifiers

PMID28639118
OpenAlexW2674020426

What OpenQuestion holds

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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.