Evidence map›Paper›PMID 28929521›Full record

Trial reportBritish journal of clinical pharmacology2018

Safety, tolerability, and pharmacokinetics of radavirsen (AVI-7100), an antisense oligonucleotide targeting influenza a M1/M2 translation.

John H Beigel, Jocelyn Voell, Paula Muñoz, Parag Kumar, Kristina M Brooks, Jianbo Zhang, Patrick Iversen, Alison Heald, Michael Wong, Richard T Davey

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

Trial report in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
1.0field-weighted citation impact, top 22% 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

18 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Antiviral Approaches against Influenza Virus.Clinical microbiology reviews · 2023
    Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Review
  15. Pharmacokinetics and Proceedings in Clinical Application of Nucleic Acid Therapeutics.Molecular therapy : the journal of the American Society of Gene Therapy · 2021
    Review
  16. RSC advances · 2020
    Review
  17. Article
  18. 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 4 institutions in 1 country.

John H BeigelLeidos Biomedical Research, Frederick, MD, USA.ORCID http://orcid.org/0000-0002-4879-4941
Jocelyn VoellNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Paula MuñozNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Parag KumarNational Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Kristina M BrooksNational Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Jianbo ZhangSarepta Therapeutics, Cambridge, MA, USA.
Patrick IversenSarepta Therapeutics, Cambridge, MA, USA.
Alison HealdSarepta Therapeutics, Cambridge, MA, USA.
Michael WongSarepta Therapeutics, Cambridge, MA, USA.
Richard T DaveyNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Sarepta Therapeutics (United States) · USNational Institutes of Health · USNational Institutes of Health Clinical Center · USLeidos (United States) · US

Funding

Influenza and Emerging Infectious DiseasesZIAAI000984 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DAVEY, RICHARD · 2009 to 2025
$44.1M
6 · The paper itself

Abstract

aimsThe aims of the present study were to assess the safety, tolerability and pharmacokinetics of radavirsen following single ascending doses and multiple doses given as intravenous infusions in healthy adults.

methodsA phase I safety and pharmacokinetic study of radavirsen was performed in healthy volunteers. The study was divided into two parts. The first was a single-ascending-dose study of five cohorts of eight subjects each, randomized 6:2 to receive single intravenous doses of radavirsen ranging from 0.5 mg kg

resultsA total of 66 subjects were screened, and 56 subjects were dosed between 2013 and 2015. At least one adverse event occurred in 31/42 (74%) who received radavirsen, and 13/14 (93%) receiving placebo. The most common adverse events were headache and proteinuria, and were similar in incidence and severity among those receiving radavirsen or placebo. Single-dose pharmacokinetics demonstrated relatively linear and dose-proportional increases in maximal concentration and in area under the concentration-time curve from zero to 24 h (AUC

conclusionSingle infusions of radavirsen up to 8 mg kg

Indexed as

AdultAntiviral AgentsDouble-Blind MethodDrug Administration ScheduleFemaleHeadacheHealthy VolunteersHumansIncidenceInfluenza A virusInfluenza, HumanInfusions, IntravenousMaleMiddle AgedMorpholinosOligonucleotides, AntisenseAntiviral AgentsM1 protein, Influenza A virusM2 protein, Influenza A virusMorpholinosOligonucleotides, AntisensePlacebosradavirsenViral Matrix ProteinsViroporin Proteinsantiviralphosphorodiamidate morpholino oligomertherapeutic

Identifiers

PMID28929521
PMCPMC5736848
OpenAlexW2757136007

What OpenQuestion holds

Textmetadata
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.