Evidence map›Paper›PMID 30674038›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2019

In-Vivo Degradation of DNA-Based Therapeutic BC 007 in Humans.

Hanna Davideit, Susanne Becker, Johannes Müller, Niels-Peter Becker, Peter Göttel, Ayşe Abay, Angela Sinn, Matthias Grossmann, Markus Mallek, Annekathrin Haberland and 1 more

Open access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2019. 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
0.2field-weighted citation impact, top 49% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  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

11 authors at 4 institutions in 1 country.

Hanna DavideitBerlin Cures GmbH, Robert-Rössle-Str. 10, Laboratory, 13125, Berlin, Germany.
Susanne BeckerDepartment of Clinical Affairs, Berlin Cures GmbH, Knesebeckstr. 59-61, 10719, Berlin, Germany.
Johannes MüllerManagement, Berlin Cures GmbH, Knesebeckstr. 59-61, 10719, Berlin, Germany.
Niels-Peter BeckerDepartment of Regulatory Affairs, Berlin Cures GmbH, Knesebeckstr. 59-61, 10719, Berlin, Germany.
Peter GöttelManagement, Berlin Cures GmbH, Knesebeckstr. 59-61, 10719, Berlin, Germany.
Ayşe AbayDepartment of Clinical Affairs, Berlin Cures GmbH, Knesebeckstr. 59-61, 10719, Berlin, Germany.
Angela SinnPAREXEL-PAREXEL International GmbH, Early Phase Clinical Unit, Klinikum Westend, Spandauer Damm 130, 14050, Berlin, Germany.
Matthias GrossmannPAREXEL-PAREXEL International GmbH, Early Phase Clinical Unit, Klinikum Westend, Spandauer Damm 130, 14050, Berlin, Germany.
Markus MallekDepartment of Toxicology and Drug-Monitoring, Medizinisches Versorgungszentrum Dr. Eberhard & Partner Dortmund, Brauhausstr. 4, 44137, Dortmund, Germany.
Annekathrin HaberlandBerlin Cures GmbH, Robert-Rössle-Str. 10, Laboratory, 13125, Berlin, Germany. haberland@berlincures.de.ORCID http://orcid.org/0000-0002-8966-1002
Hardy WeisshoffDepartment of Chemistry, NMR Facility, Humboldt University of Berlin, Brook-Taylor-Straße 2, 12489, Berlin, Germany.
Berlin Heart (Germany) · DECenter for HIV and Hepatogastroenterology · DEHumboldt-Universität zu Berlin · DERobert Koch Institute · DE

Funding

AiF support GmbH, ZIM ZF4447101AJ7
6 · The paper itself

Abstract

BACKGROUND AND

objectivesSince there is no clear evidence in the literature to show how non-modified single-stranded DNA (ssDNA) drugs are metabolized in humans, we assessed the metabolism of BC 007, an ssDNA therapeutic, under development as a neutralizer of autoantibodies against G-protein-coupled receptors. In-vitro, investigating its stability in monkey plasma and serum, a successive 3'-exonuclease degradation resulting in several n-x degradation products has been previously reported. Here, we investigated the metabolism of BC 007 in humans after intravenous application to autoantibody-positive healthy subjects, in line with Phase I safety testing.

methods

resultsFast degradation prohibited the detection of the intermediate n-x degradation products in urine using

conclusionFast and full degradation of BC 007, shown by nucleic bases degradation products, is one of the first reports about the fate of a ssDNA product in humans.

Indexed as

AdolescentAdultAgedAminoisobutyric AcidsAutoantibodiesDNADouble-Blind MethodFemaleHealthy VolunteersHumansMagnetic Resonance SpectroscopyMaleMiddle AgedOligonucleotidesYoung Adult3-aminoisobutyric acidAminoisobutyric AcidsAutoantibodiesDNAOligonucleotides

Identifiers

PMID30674038
PMCPMC6617257
OpenAlexW2913579412

What OpenQuestion holds

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LicenceCC BY-NC
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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.