Evidence map›Paper›PMID 32045493›Full record

Trial reportBritish journal of clinical pharmacology2020

Safety, tolerability, pharmacokinetics and pharmacodynamics of the anti-CD38 cytolytic antibody TAK-079 in healthy subjects.

Eric R Fedyk, Lin Zhao, Annelize Koch, Glennda Smithson, Jose Estevam, Grace Chen, Gezim Lahu, Stefan Roepcke, Jianchang Lin, Lachy Mclean

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 9% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. CD38 as theranostic target in oncology.Journal of translational medicine · 2024
    Review
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  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
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  19. Antibody Therapies in Autoimmune Neuromuscular Junction Disorders: Approach to Myasthenic Crisis and Chronic Management.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  20. 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

10 authors at 3 institutions in 4 countries.

Eric R FedykTakeda Pharmaceuticals International, Deerfield, IL, USA.ORCID 0000-0002-5503-7172
Lin ZhaoTakeda Pharmaceuticals International, Deerfield, IL, USA.
Annelize KochParexel, Harrow, UK.
Glennda SmithsonTakeda Pharmaceuticals International, Deerfield, IL, USA.
Jose EstevamTakeda Oncology, Cambridge, MA, USA.
Grace ChenTakeda Pharmaceuticals International, Deerfield, IL, USA.
Gezim LahuTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Stefan RoepckeTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Jianchang LinTakeda Oncology, Cambridge, MA, USA.
Lachy McleanTakeda California, San Diego, CA, USA.
Takeda (United States) · USTakeda (Switzerland) · CHPAREXEL International (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThis investigation characterised tolerability, pharmacokinetics and pharmacodynamics of the anti-CD38 antibody TAK-079.

methodsA randomised, double-blind, placebo-controlled trial of a single intravenous (i.v.) infusion or subcutaneous (s.c.) injection of TAK-079 at escalating doses in healthy subjects (n = 74), who were followed for 92 days postexposure.

resultsTAK-079 was well tolerated. All adverse events were mild or moderate. There were no withdrawals, infusion, or injection site reactions over the tested i.v. and s.c. doses up to 0.06 and 0.6 mg kg

conclusionsTAK-079 was well tolerated and s.c. administration elicited more durable reductions in plasmablasts and NK cells. This plasmacytolytic profile could be useful for treating disorders caused by plasma or NK cells, malignant counterparts, and/or pathogenic antibodies.

Indexed as

Antibodies, MonoclonalAntineoplastic AgentsDose-Response Relationship, DrugDouble-Blind MethodHealthy VolunteersHumansKiller Cells, NaturalAntibodies, MonoclonalAntineoplastic Agentsanticancer drugs, monoclonal antibodies, pharmacokinetic-pharmacodynamic, phase I, rheumatology

Identifiers

PMID32045493
PMCPMC7319013
OpenAlexW3005659282

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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 OpenQuestion graph.