Evidence map›Paper›PMID 39368043›Full record

Trial reportDrugs in R&D2024

Pharmacokinetics, Pharmacodynamics, and Safety of Intravenous Efgartigimod and Subcutaneous Efgartigimod PH20 in Healthy Chinese Participants.

Shan Jing, Yu Zhang, Yang Lin, Xiaowen Gu, Jing Liu, Antonio Guglietta, Jan Noukens, Tonke Van Bragt, Lina Wang, Jiajia Chen and 2 more

Abstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drugs in R&D, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  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

12 authors.

Shan JingBeijing Anzhen Hospital, Capital Medical University, Beijing, China.
Yu ZhangUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Yang LinBeijing Anzhen Hospital, Capital Medical University, Beijing, China.
Xiaowen GuZai Lab (Shanghai) Co., Ltd, Shanghai, China.
Jing LiuZai Lab (Shanghai) Co., Ltd, Shanghai, China.
Antonio Gugliettaargenx, Ghent, Belgium.
Jan NoukensCurare Consulting B.V., Liempde, the Netherlands.
Tonke Van BragtCurare Consulting B.V., Liempde, the Netherlands.
Lina WangZai Lab (Shanghai) Co., Ltd, Shanghai, China.
Jiajia ChenZai Lab (Shanghai) Co., Ltd, Shanghai, China.
Harald ReinhartZai Lab (US) LLC, Cambridge, MA, USA.
Xia PuZai Lab (US) LLC, Cambridge, MA, USA. xia.pu@zailaboratory.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEfgartigimod, a human immunoglobulin G (IgG)1-derived Fc fragment targeting the neonatal Fc receptor, has been developed into intravenous (IV) and subcutaneous (SC) formulations for treating generalized myasthenia gravis (gMG) and other autoimmune diseases. Data in the Chinese population were not available to date, and while both formulations have been approved in the USA, the EU, Japan and China for the treatment of gMG.

objectiveWe present the pharmacokinetic, pharmacodynamic, and safety of IV and SC PH20 efgartigimod in healthy Chinese participants.

methodsIn two independent, double-blinded, placebo-controlled, phase I studies of the IV and SC formulations of efgartigimod, healthy Chinese adults were randomized 3:1 to receive active treatment or matching placebo once every 7 days for four doses. Primary endpoints were pharmacokinetic parameters.

resultsAfter the fourth IV infusion, a mean maximum observed concentration (C

conclusionsThe efgartigimod IV and SC pharmacokinetic, pharmacodynamic, and safety profiles in Chinese participants were similar to the known profiles in non-Chinese participants. Both formulations effectively reduced total IgG levels by a similar percentage. CLINICAL

trial registrationCTR20211952 and CTR20211805.

Indexed as

Antibodies, Monoclonal, HumanizedAdultArea Under CurveChinaDouble-Blind MethodEast Asian PeopleFemaleHealthy VolunteersHistocompatibility Antigens Class IHumansImmunoglobulin Fc FragmentsImmunoglobulin GInfusions, IntravenousInjections, SubcutaneousMaleMiddle AgedAntibodies, Monoclonal, Humanizedefgartigimod alfaFc receptor, neonatalHistocompatibility Antigens Class IImmunoglobulin Fc FragmentsImmunoglobulin GReceptors, Fc

Identifiers

PMID39368043
PMCPMC11652471

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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.