Evidence map›Paper›PMID 35844038›Full record

Trial reportClinical pharmacology in drug development2022

Pharmacokinetic Characteristics, Safety, and Tolerability of Telitacicept, an Injectable Recombinant Human B-Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein, in Healthy Chinese Subjects.

Jing Xie, Xiaoyun Fan, Yue Su, Huan Zhou, Shugang Cao, Xingyu Zhu, Minhui Zhu, Cuixia He, Ying Wang, Ling Fan and 10 more

Open access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Clinical pharmacology in drug development, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 11% 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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
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  19. Article
  20. Telitacicept for autoimmune nephropathy.Frontiers in immunology · 2023
    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

20 authors at 4 institutions in 1 country.

Jing XieNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Xiaoyun FanNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Yue SuNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Huan ZhouNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Shugang CaoNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Xingyu ZhuNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Minhui ZhuNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Cuixia HeNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Ying WangNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Ling FanNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Qin GeNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Juan ZhuNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Bingyan LiuNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Xiao ChenNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Yunqiu XieNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Ling MaNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Yuanyuan LiuNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Juan ChenNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Huaxue WangNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Zhijun LiNational Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
First Affiliated Hospital of Bengbu Medical College · CNBengbu Medical College · CNFirst Affiliated Hospital of Anhui Medical University · CNFirst Affiliated Hospital of Jinan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Telitacicept, an injectable recombinant human B-lymphocyte stimulating factor receptor-antibody fusion protein, is a new dual B lymphocyte stimulator (BLyS)/APRIL (a proliferation-inducing ligand) inhibitor that effectively blocks proliferation of B lymphocytes. This study evaluates the pharmacokinetic characteristics, tolerability, and safety of a single subcutaneous injection of various doses (80, 160, and 240 mg) of telitacicept in healthy Chinese subjects. This trial is a single-center, randomized, open-label phase I clinical study that includes three dose groups (80, 160, and 240 mg) with 12 subjects in each dose group. The subjects were randomly assigned to different dose groups in a 1:1:1 ratio for a single subcutaneous administration trial. After a single dose, the maximum serum concentration (C

Indexed as

B-LymphocytesImmunosuppressive AgentsChinaDose-Response Relationship, DrugHealthy VolunteersHumansRecombinant Fusion ProteinsImmunosuppressive AgentsRecombinant Fusion ProteinsBLyS/APRILpharmacokineticssafetytelitacicepttolerability

Identifiers

PMID35844038
PMCPMC9796261
OpenAlexW4285731823

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.