Evidence map›Paper›PMID 32222912›Full record

Trial reportClinical drug investigation2020

A Three-Part, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Mode of Action of BC 007, Neutraliser of Pathogenic Autoantibodies Against G-Protein Coupled Receptors in Healthy, Young and Elderly Subjects.

Niels-Peter Becker, Annekathrin Haberland, Katrin Wenzel, Peter Göttel, Gerd Wallukat, Hanna Davideit, Sarah Schulze-Rothe, Anne-Sophie Hönicke, Ingolf Schimke, Sabine Bartel and 8 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical drug investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02955420 (A Three-part, Randomized Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BC 007 in Healthy, Young Subjects and Elderly Subjects), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.9field-weighted citation impact, top 12% 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.

NCT02955420 phase1completednot on this map

A Three-part, Randomized Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BC 007 in Healthy, Young Subjects and Elderly Subjects

TypeinterventionalSponsorBerlin Cures GmbHRan2016 to 2018Enrolled74ConditionsHealthy VolunteersArmsBC 007, NaCl 0.9 %
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 21 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Aptamers-Diagnostic and Therapeutic Solution in SARS-CoV-2.International journal of molecular sciences · 2022
    Review
  8. Aptamers Against COVID-19: An Untested Opportunity.Mini reviews in medicinal chemistry · 2022
    Article
  9. Article
  10. Article
  11. Article
  12. 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

18 authors at 3 institutions in 2 countries.

Niels-Peter BeckerBerlin Cures GmbH, Dept. Regulatory Affairs, Knesebeck Str. 59-61, 10719, Berlin, Germany.
Annekathrin HaberlandBerlin Cures GmbH, Dept. Regulatory Affairs, Robert-Rössle-Str. 10, 13125, Berlin, Germany. haberland@berlincures.de.ORCID http://orcid.org/0000-0002-8966-1002
Katrin WenzelBerlin Cures GmbH, Laboratory, Robert-Rössle-Str. 10, 13125, Berlin, Germany.
Peter GöttelBerlin Cures GmbH, COO, Knesebeck Str. 59-61, 10719, Berlin, Germany.
Gerd WallukatBerlin Cures GmbH, Laboratory, Robert-Rössle-Str. 10, 13125, Berlin, Germany.
Hanna DavideitBerlin Cures GmbH, Dept. Quality Management, Robert-Rössle-Str. 10, 13125, Berlin, Germany.
Sarah Schulze-RotheBerlin Cures GmbH, Laboratory, Robert-Rössle-Str. 10, 13125, Berlin, Germany.
Anne-Sophie HönickeBerlin Cures GmbH, Laboratory, Robert-Rössle-Str. 10, 13125, Berlin, Germany.
Ingolf SchimkeBerlin Cures GmbH, Laboratory, Robert-Rössle-Str. 10, 13125, Berlin, Germany.
Sabine BartelBerlin Cures GmbH, Laboratory, Robert-Rössle-Str. 10, 13125, Berlin, Germany.
Matthias GrossmannParexel International GmbH, Berlin, Germany.
Angela SinnParexel International GmbH, Berlin, Germany.
Laura IavaroneParexel International GmbH, Berlin, Germany.
Jan H BoergermannParexel International GmbH, Berlin, Germany.
Kiley PrillimanParexel International GmbH, Berlin, Germany.
Georg GolorParexel International GmbH, Berlin, Germany.
Johannes MüllerBerlin Cures GmbH, CEO, Knesebeck Str. 59-61, 10719, Berlin, Germany.
Susanne BeckerBerlin Cures GmbH, Clinical Operations, Knesebeck Str. 59-61, 10719, Berlin, Germany.
Berlin Heart (Germany) · DEBerlin School of Economics and Law · DEBioNet Lab (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveBC 007 is a substance with a novel and innovative mode of action for the first-time causal treatment of chronic heart failure, associated with the occurrence of autoantibodies against the β1-adrenoceptor, and other diseases of mostly the heart and vascular system, being accompanied by the occurrence of functionally active agonistic autoantibodies against G-protein-coupled receptors (

methodsThis study was subdivided into three parts. Part A was a single-centre, randomised, double-blind, placebo-controlled safety and tolerability study including healthy young male autoantibody-negative Whites (N = 23) and Asians (N = 1), testing doses of 15, 50 and 150 mg BC 007 (Cohorts 1-3) and elderly male and female Whites (N = 8), testing a dose of 150 mg BC 007 (Cohort 4), randomly assigned in a 3:1 ratio to BC 007 or placebo. Open-label Part B included

resultsThe mean observed BC 007 area under the concentration-time curve (AUC

conclusionBC 007 is demonstrated to be safe and well tolerated. BC 007 neutralised GOV REGISTRATION NUMBER: NCT02955420.

Indexed as

AdultAgedAutoantibodiesDose-Response Relationship, DrugDouble-Blind MethodFemaleHeart FailureHumansInfusions, IntravenousMaleMiddle AgedNeutralization TestsPlacebosReceptors, G-Protein-CoupledYoung AdultAutoantibodiesPlacebosReceptors, G-Protein-Coupled

Identifiers

PMID32222912
PMCPMC7181550
OpenAlexW3013902721

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.